510(k) K171650 ยท LCP Assay, Glycosylated Hemoglobin
Alere Afinion HbA1c and ACR on Afinion 2 analyzer
| Applicant | Abbott Rapid Diagnostics, San Diego CA, US |
| Decision | Substantially Equivalent, Nov 21, 2017 |
| Received | Jun 5, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K171650
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST KIT. Open, Classified |
LCP | None listed |
| Aug 27, 2024 | Abbott Diagnostics Technologies AS Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived. Open, Classified |
LCP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.