510(k) K993317 ยท JHI Visual, Pregnancy Hcg, Prescription Use
ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE)
| Applicant | ACON Laboratories, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Dec 1, 1999 |
| Received | Oct 4, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993317
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2026 | Alere San Diego, Inc. Fisher Scientific Sure-Vue Urine hCG, Model/ Part: FHC-102/23900526;
Henry Schein, Inc. One Step + Urine Cassette Test, Model/ Part: FHC-102/9004074, FHC-102/9004073;
Alere hCG Cassette (25mIU/mL) in Open, Classified |
JHI | None listed |
| May 21, 2013 | Alere San Diego, Inc. Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 4582105026)
The SP hCG Cassette Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human chorio Terminated |
JHI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.