510(k) K974059 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
ONE STEP MIDSTREAM HCG PREGNANCY TEST
| Applicant | International Newtech Development, Inc., Delta, B.C., CA |
| Decision | Substantially Equivalent, Apr 9, 1998 |
| Received | Oct 27, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974059
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2023 | Universal Meditech Inc. Am I Pregnant? One Step HCG Pregnancy Test REF 100-17 Open, Classified |
LCX | None listed |
| Oct 23, 2023 | Universal Meditech Inc. PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS Open, Classified |
LCX | None listed |
| Oct 23, 2023 | Universal Meditech Inc. DiagnosUS Pregnancy Test Midstream REF 100-17 Open, Classified |
LCX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.