510(k) K962521 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
FACTPLUS ONE STEP PREGNANCY TEST
| Applicant | Direct Access Diagnostics, Bridgewater NJ, US |
| Decision | Substantially Equivalent, Jul 29, 1996 |
| Received | Jun 19, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962521
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.