Reference Source

H&D Srl · 89-08 · ITALY

For H&D Srl, import alert is 89-08; country is ITALY; 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 FRAS 5 (Free Radical Analytical System) Device & Sample Kit | FRAS 5 (Free Radical Analytical System) Device & Sample Kit; product code is 75 J - - JE Analyzer, Chemistry (Photometric, Discrete) For Clinical Use | 83 O - - TT Research use only/microbiology; date published is 10/23/2019; address is Strada Langhirano 264/1a , Parma, Parma ITALY, verified against its source on 2026-09-30.

Firm
H&D Srl 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
ITALY verified
Address
Strada Langhirano 264/1a , Parma, Parma ITALY verified
Date published
10/23/2019 verified
Product code
75 J - - JE Analyzer, Chemistry (Photometric, Discrete) For Clinical Use | 83 O - - TT Research use only/microbiology each item verified
Product
FRAS 5 (Free Radical Analytical System) Device & Sample Kit | FRAS 5 (Free Radical Analytical System) Device & Sample Kit 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

H&D Srl Date Published : 10/23/2019 Strada Langhirano 264/1a , Parma, Parma ITALY

— 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 and Product

75 J - - JE Analyzer, Chemistry (Photometric, Discrete) For Clinical Use Date Published: 10/23/2019 Desc: FRAS 5 (Free Radical Analytical System) Device & Sample Kit 83 O - - TT Research use only/microbiology Date Published: 10/23/2019 Desc: FRAS 5 (Free Radical Analytical System) Device & Sample Kit

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

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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