510(k) K123050 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II)
| Applicant | Nantong Biotechnology Co., Ltd., Gaithersburg MD, US |
| Decision | Substantially Equivalent, Feb 5, 2013 |
| Received | Sep 28, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123050
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.