510(k) K123703 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE)
| Applicant | Healgen Scientific,, LLC, Houston TX, US |
| Decision | Substantially Equivalent, Apr 10, 2013 |
| Received | Dec 3, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123703
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 7, 2023 | Family Dollar Stores, Llc. VERIQUICK PREGNANCY TEST 1CT, SKU 901260 Open, Classified |
LCX | None listed |
| Aug 17, 2022 | Family Dollar Stores, Llc. VERIQUICK PREGNANCY TEST 1CT, SKU 901260, 939504 Open, Classified |
LCX | None listed |
| Aug 17, 2022 | Family Dollar Stores, Llc. Veriquick Pregnancy Test 2CT, SKU 903756 Open, Classified |
LCX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.