510(k) K823313 ยท JHI Visual, Pregnancy Hcg, Prescription Use
IN VITRO GAMMACOAT B-HCG RADIO. TEST
| Applicant | Clinical Assays, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Dec 22, 1982 |
| Received | Nov 5, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K823313
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.