510(k) K043443 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
ONE STEP HCG URINE PREGNANCY TEST
| Applicant | Guangzhou Wondfo Biotech Co., Ltd., Yardley PA, US |
| Decision | Substantially Equivalent, Apr 8, 2005 |
| Received | Dec 14, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043443
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.