510(k) K062203 ยท GHH Fibrin Split Products
TINA-QUANT D-DIMER TEST SYSTEM
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Mar 14, 2007 |
| Received | Aug 1, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062203
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 20, 2023 | Roche Diagnostics Operations, Inc. Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502; INTEGRA 400 plus), 08105618190 - (cobas c 303 and 503) Open, Classified |
GHH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.