Shenyang Eksv Medical Equipment · 89-08 · CHINA
For Shenyang Eksv Medical Equipment · 89-08 · CHINA, import alert is 89-08; 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)"; country is CHINA; 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 2026-09-16.
- 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
What the source says
Shenyang Eksv Medical Equipment Date Published : 10/31/2011 30 North Xinghua , Shenyang, CHINA 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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html