510(k) K914304 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
FIRST RESPONSE(R) ONE-STEP
| Applicant | Armkel, LLC, Cranbury NJ, US |
| Decision | Substantially Equivalent, Oct 17, 1991 |
| Received | Sep 25, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K914304
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.