510(k) K050305 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
ONE STEP HCG PREGNANCY URINE TEST FORMATS: STRIP, CASSETTE AND MIDSTREAM, MODELS BM-1-1, BM-1-2, BM-1-3, BM-2-1, BM-2-2
| Applicant | Bioscreen Medical, Inc., Mildred PA, US |
| Decision | Substantially Equivalent, May 23, 2005 |
| Received | Feb 8, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050305
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.