510(k) K072714 ยท LCP Assay, Glycosylated Hemoglobin
TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 18, 2008 |
| Received | Sep 25, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K072714
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 11, 2016 | Roche Diagnostics Operations, Inc. Tina-Quant Hemoglobin A1c Gen. 2
Hemoglobin A1c test
Catalog number 04528123190 / 05401640190 Terminated |
LCP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.