H&D Srl · 89-08 · ITALY
For H&D Srl · 89-08 · ITALY, 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 ITALY; 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 2026-09-16.
- 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 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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.