510(k) K020831 ยท GJS Test, Time, Prothrombin
PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND 3271404
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Oct 24, 2002 |
| Received | Mar 14, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020831
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.