510(k) K871680 ยท LAN Enzyme Immunoassay, N-Acetylprocainamide
MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR
| Applicant | Roche Diagnostic Systems, Inc., Nutley NJ, US |
| Decision | Substantially Equivalent, Jun 8, 1987 |
| Received | Apr 29, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K871680
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.