510(k) K941440 ยท LBZ Enzyme Immunoassay, Quinidine
COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS
| Applicant | Roche Diagnostic Systems, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Jul 6, 1994 |
| Received | Mar 24, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K941440
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.