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
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
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html