510(k) K052464 ยท LCP Assay, Glycosylated Hemoglobin
TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Sep 30, 2005 |
| Received | Sep 8, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K052464
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.