510(k) K964108 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
FACT PLUS PREGNANCY TEST
| Applicant | Direct Access Diagnostics, Bridgewater NJ, US |
| Decision | Substantially Equivalent, Nov 18, 1996 |
| Received | Oct 15, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964108
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.