510(k) K901547 ยท KXT Enzyme Immunoassay, Digoxin
OPUS(TM) DIGOXIN TEST SYSTEM
| Applicant | Pb Diagnostic Systems, Inc., Westwood MA, US |
| Decision | Substantially Equivalent, Jun 26, 1990 |
| Received | Apr 3, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K901547
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.