510(k) K903219 ยท JHI Visual, Pregnancy Hcg, Prescription Use
ABBOTT TESTPACK PLUS TM HCG-COMBO
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Sep 25, 1990 |
| Received | Jul 23, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K903219
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 24, 2005 | Abbott Laboratories MPG ABBOTT TestPack +Plus hCG Combo, list 3A60-16; the kit contains 20 reaction discs, anti-beta hCG (Goat) and anti-alpha hCG (Mouse, Monoclonal) coated, and 20 transfer pipettes; Abbott Laboratories, Ab Terminated |
JHI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.