510(k) K934762 ยท LAR Enzyme Immunoassay, Procainamide
OPUS PROCAINAMIDE TEST SYSTEM
| Applicant | Pb Diagnostic Systems, Inc., Westwood MA, US |
| Decision | Substantially Equivalent, Jul 20, 1994 |
| Received | Oct 4, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934762
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.