# H&D Srl · 89-08 · ITALY — FDA import alert red lists: firms subject to detention without physical examination

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

## 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

## Source

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

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).