510(k) K993203 ยท JHI Visual, Pregnancy Hcg, Prescription Use
ACON ONE STEP PREGNANCY TEST STRIP (URINE)
| Applicant | ACON Laboratories, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Dec 1, 1999 |
| Received | Sep 24, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993203
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2026 | Alere San Diego, Inc. Fisher Scientific Sure-Vue Urine hCG Strip, Model/ Part: FHC-101/23900527;
McKesson CONSULT hCG Urine Test Dipstick CLIA Waived, Model/ Part:FHC-101/5000;
Henry Schein One Step+ hCG Urine Strip Test, Open, Classified |
JHI | None listed |
| Aug 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office a. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere Fertility Test hCG Pregnancy Test Urine Sample 30 Tests, Model Number: 92210.
b. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere Open, Classified |
JHI | None listed |
| Apr 2, 2003 | Beckman Coulter Inc ICON DS hCG, an in-vitro diagnostic. Part number 44025. Terminated |
JHI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.