Reference Source

Shenyang Eksv Medical Equipment · 89-08 · CHINA

For Shenyang Eksv Medical Equipment, import alert is 89-08; country is CHINA; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product is EKSV-10A Urinalysis Test Strips | EKSV-10A Urinalysis Test Strips | EKSV-10A Urinalysis Test Strips | EKSV-10A Urinalysis Test Strips | EKSV-10A Urinalysis Test Strips | EKSV-10A Urinalysis Test Strips | EKSV-10A Urinalysis Test Strips | EKSV-10A Urinalysis Test Strips | EKSV-10A Urinalysis Test Strips | EKSV-10A Urinalysis Test Strips; product code is 75 C - - DM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | 75 C - - EN Dye-Indicator, Ph (Urinary, Non-Quant.) | 75 J - - IL Enzymatic Method, Glucose (Urinary, Non-Quant.) | 75 J - - IN Nitroprusside, Ketones (Urinary, Non-Quant.) | 75 J - - IR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | 75 J - - JB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | 75 J - - MT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | 81 J - - IO Blood, Occult, Colorimetric, in Urine | 81 L - - JX Test, Urine Leukocyte | 83 J - - XA Kit, Screening, Urine; date published is 10/31/2011; address is 30 North Xinghua , Shenyang, CHINA, verified against its source on 2026-09-30.

Firm
Shenyang Eksv Medical Equipment verified
Import alert
89-08
Import alert name
"Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
Country
CHINA verified
Address
30 North Xinghua , Shenyang, CHINA verified
Date published
10/31/2011 verified
Product code
75 C - - DM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | 75 C - - EN Dye-Indicator, Ph (Urinary, Non-Quant.) | 75 J - - IL Enzymatic Method, Glucose (Urinary, Non-Quant.) | 75 J - - IN Nitroprusside, Ketones (Urinary, Non-Quant.) | 75 J - - IR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | 75 J - - JB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | 75 J - - MT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | 81 J - - IO Blood, Occult, Colorimetric, in Urine | 81 L - - JX Test, Urine Leukocyte | 83 J - - XA Kit, Screening, Urine each item verified
Product
EKSV-10A Urinalysis Test Strips | EKSV-10A Urinalysis Test Strips | EKSV-10A Urinalysis Test Strips | EKSV-10A Urinalysis Test Strips | EKSV-10A Urinalysis Test Strips | EKSV-10A Urinalysis Test Strips | EKSV-10A Urinalysis Test Strips | EKSV-10A Urinalysis Test Strips | EKSV-10A Urinalysis Test Strips | EKSV-10A Urinalysis Test Strips each item verified
FDA notes
class II | class II | Class II | class II | class II | class II | Class II | class II | Class II | Class II each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Shenyang Eksv Medical Equipment Date Published : 10/31/2011 30 North Xinghua , Shenyang, CHINA

— accessdata.fda.gov, retrieved 2026-09-15

Where each value comes from

The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.

Product code, Product and FDA notes

75 C - - DM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) Date Published: 10/31/2011 Desc: EKSV-10A Urinalysis Test Strips Notes: class II 75 C - - EN Dye-Indicator, Ph (Urinary, Non-Quant.) Date Published: 10/31/2011 Desc: EKSV-10A Urinalysis Test Strips Notes: class II 75 J - - IL Enzymatic Method, Glucose (Urinary, Non-Quant.) Date Published: 10/31/2011 Desc: EKSV-10A Urinalysis Test Strips Notes: Class II 75 J - - IN Nitroprusside, Ketones (Urinary, Non-Quant.) Date Published: 10/31/2011 Desc: EKSV-10A Urinalysis Test Strips Notes: class II 75 J - - IR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) Date Published: 10/31/2011 Desc: EKSV-10A Urinalysis Test Strips Notes: class II 75 J - - JB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) Date Published: 10/31/2011 Desc: EKSV-10A Urinalysis Test Strips Notes: class II 75 J - - MT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) Date Published: 10/31/2011 Desc: EKSV-10A Urinalysis Test Strips Notes: Class II 81 J - - IO Blood, Occult, Colorimetric, in Urine Date Published: 10/31/2011 Desc: EKSV-10A Urinalysis Test Strips Notes: class II 81 L - - JX Test, Urine Leukocyte Date Published: 10/31/2011 Desc: EKSV-10A Urinalysis Test Strips Notes: Class II 83 J - - XA Kit, Screening, Urine Date Published: 10/31/2011 Desc: EKSV-10A Urinalysis Test Strips Notes: Class II

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

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