510(k) K923925 ยท JHI Visual, Pregnancy Hcg, Prescription Use
HCG STAT-PAK
| Applicant | Chembio Diagnostic Systems, Inc., Medford NY, US |
| Decision | Substantially Equivalent, Dec 24, 1992 |
| Received | Aug 5, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K923925
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.