510(k) K182988 ยท PDJ Hemoglobin A1c Test System
Afinion HbA1c Dx on Afinion 2
| Applicant | Alere Technologies AS, Oslo, NO |
| Decision | Substantially Equivalent, Nov 29, 2018 |
| Received | Oct 29, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K182988
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 23, 2020 | Abbott Diagnostics Technologies AS Power supply provided with Afinion 2, Catalog numbers 1116553, 1116554, 1116556, 1116557, 1116597, 1116598, 1116663, 1116679, 1116680, 1116681, 1116682, 1116684, 1116770, 1116771, 1116772, 1116777, 11 Open, Classified |
PDJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.