510(k) K883639 ยท JHI Visual, Pregnancy Hcg, Prescription Use
MODIFIED HCG IRMA KIT
| Applicant | Pacific Biotech, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Oct 6, 1988 |
| Received | Aug 25, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K883639
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.