510(k) K852320 ยท LAR Enzyme Immunoassay, Procainamide
COBAS FP REAGEN FOR PROCAINAMIDE & PRO CALIBRATOR
| Applicant | Roche Diagnostic Systems, Inc., Nutley NJ, US |
| Decision | Substantially Equivalent, Jul 9, 1985 |
| Received | May 31, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K852320
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.