510(k) K053138 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
MYSET PREGNANCY TEST
| Applicant | Ani Biotech OY, Beverly MA, US |
| Decision | Substantially Equivalent, Mar 1, 2006 |
| Received | Nov 9, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053138
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.