510(k) K854059 ยท JHI Visual, Pregnancy Hcg, Prescription Use
MICRO-ELISA HCG EST KIT VISI-CHECK HCG TEST KIT NO
| Applicant | Bioclinical Systems, Inc., St.Louis MO, US |
| Decision | Substantially Equivalent, Jan 13, 1986 |
| Received | Oct 3, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854059
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.