510(k) K993065 ยท JHI Visual, Pregnancy Hcg, Prescription Use
ACON COMBO PREGNANCY
| Applicant | ACON Laboratories, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Oct 8, 1999 |
| Received | Sep 13, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993065
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2026 | Alere San Diego, Inc. Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528;
Beckman Coulter Inc's ICON 25 hCG, Model/ Part: FHC-202/43025;
Henry Schein One Step+ hCG Combo test in S Open, Classified |
JHI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.