510(k) K002609 ยท DHR System, Test, Rheumatoid Factor
TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Sep 5, 2000 |
| Received | Aug 22, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002609
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 19, 2003 | Roche Diagnostics Corp. Roche/Hitachi Tina-quant RF II; catalog # 3004902 Terminated |
None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.