510(k) K110313 ยท LCP Assay, Glycosylated Hemoglobin
TINA-QUANT HBA1C GEN.2
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Dec 23, 2011 |
| Received | Feb 2, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110313
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.