510(k) K965116 ยท JHI Visual, Pregnancy Hcg, Prescription Use
ABBOTT TESTPACK PLUS HCG COMBO WITH OBC
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Feb 20, 1997 |
| Received | Dec 20, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K965116
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 24, 2005 | Abbott Laboratories MPG ABBOTT TestPack +Plus hCG Combo with On Board Controls (OBC), list number 7B34-16; the kit contains 20 reaction discs, Anti-beta hCG (Goat) and Anti-alpha hCG (Mouse, Monoclonal) coated; Abbott Labora Terminated |
JHI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.