510(k) K032535 ยท DHR System, Test, Rheumatoid Factor
MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Sep 10, 2003 |
| Received | Aug 18, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K032535
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.