510(k) K850570 ยท JHI Visual, Pregnancy Hcg, Prescription Use
STRATUS HCG FLUOROMETRIC ENZYME IMMUNOASSAY
| Applicant | American Dade, Santa Ana CA, US |
| Decision | Substantially Equivalent, Apr 2, 1985 |
| Received | Feb 13, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K850570
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.