510(k) K913938 ยท CEP Radioimmunoassay, Luteinizing Hormone
OPUS(R) LH TEST SYSTEM
| Applicant | Pb Diagnostic Systems, Inc., Westwood MA, US |
| Decision | Substantially Equivalent, Nov 7, 1991 |
| Received | Sep 3, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913938
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.