510(k) DEN130002 ยท PDJ Hemoglobin A1c Test System
TINA-QUANT HBA1C GEN. 2 TEST SYSTEM
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Unknown, May 23, 2013 |
| Received | Mar 25, 2013 |
| Type | Post-NSE |
| FDA record | Open on fda.gov |
Recalls that name DEN130002
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.