510(k) K012215 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
QUIK-CHECK HOME PREGNANCY TEST
| Applicant | ACON Laboratories, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Aug 7, 2001 |
| Received | Jul 16, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012215
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.