510(k) K872728 ยท JHI Visual, Pregnancy Hcg, Prescription Use
BINAX IRMA TOTAL BETA-HCG TEST KIT
| Applicant | Binax, Inc., S. Portland ME, US |
| Decision | Substantially Equivalent, Aug 5, 1987 |
| Received | Jul 8, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K872728
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.