510(k) K061683 ยท DDR Myoglobin, Antigen, Antiserum, Control
TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jul 21, 2006 |
| Received | Jun 15, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061683
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 2, 2019 | Roche Diagnostics Operations, Inc. The Tina-Quant Myoglobin Gen. 2 Tests system is an immuno-turbidimetric assay for the quantitative in vitro determination of myoglobin in human serum and plasma on Roche automated clinical chemistry a Terminated |
DDR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.