510(k) K942847 ยท LAR Enzyme Immunoassay, Procainamide
COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR
| Applicant | Roche Diagnostic Systems, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Dec 2, 1994 |
| Received | Jun 16, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K942847
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.