510(k) K850992 ยท JHI Visual, Pregnancy Hcg, Prescription Use
PREGNA-ZYME
| Applicant | Armkel, LLC, Cranbury NJ, US |
| Decision | Substantially Equivalent, May 1, 1985 |
| Received | Mar 11, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K850992
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.