510(k) K932279 ยท JHI Visual, Pregnancy Hcg, Prescription Use
OPUS(R) TOTAL B-HCG TEST SYSTEM
| Applicant | Pb Diagnostic Systems, Inc., Westwood MA, US |
| Decision | Substantially Equivalent, Jul 8, 1993 |
| Received | May 12, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K932279
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.