510(k) K912535 ยท JHI Visual, Pregnancy Hcg, Prescription Use
IMX TOTAL B-HCG
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Jul 1, 1991 |
| Received | Jun 7, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912535
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 16, 2005 | Abbott Health Products, Inc. IMx total B-hCG Reagent is composed of one bottle of Coated Microparticles, one bottle of Alkaline Phosphatase Conjugate, one bottle of 4 Methylumbelliferyl Phosphate and one bottle of Specimen Diluen Terminated |
JHI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.