510(k) K110889 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
IND ONE STEP HCG URINE PREGNANCY TEST (STRIP)
| Applicant | Ind Diagnostics, Inc., Delta, B.C., CA |
| Decision | Substantially Equivalent, Jun 20, 2011 |
| Received | Mar 30, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110889
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2023 | Universal Meditech Inc. One Step Pregnancy Test REF 100-01 Open, Classified |
LCX | None listed |
| Oct 23, 2023 | Universal Meditech Inc. PrestiBio Ovulation and Pregnancy Strips REF 100-4 and REF 200-4 60 LH Test Strips/+30 HCF Test Strips Open, Classified |
NGE | None listed |
| Oct 23, 2023 | Universal Meditech Inc. PrestiBio Pregnancy Strips REF 100-4 25 HCG Test Strips Open, Classified |
LCX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.