510(k) K853258 ยท JHI Visual, Pregnancy Hcg, Prescription Use
BETA-HCG MICROTITER PREGNANCY TEST
| Applicant | Modern Diagnostics, Inc., Sacramento CA, US |
| Decision | Substantially Equivalent, Oct 1, 1985 |
| Received | Aug 2, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853258
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.