510(k) K854611 ยท JHI Visual, Pregnancy Hcg, Prescription Use
RAMP URINE HCG ASSAY
| Applicant | Monoclonal Antibodies, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Dec 30, 1985 |
| Received | Nov 18, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854611
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.