510(k) K935673 ยท JHI Visual, Pregnancy Hcg, Prescription Use
AXSYM TOTAL B-HCG
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Jun 21, 1994 |
| Received | Nov 26, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935673
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 12, 2007 | Abbott Diagnostic International, Ltd. AxSYM Total B-hCG Reagent List 7A59-21 is composed of one bottle of Anti B-hCG Coated Microparticles, one bottle of Anti- B-hCG Alkaline Phosphatase Conjugate and one bottle of Specimen Diluent. REF 7 Terminated |
JHI | None listed |
| Jul 12, 2007 | Abbott Diagnostic International, Ltd. AxSYM Total B-hCG Reagent List 7A59-22 is composed of one bottle of Anti B-hCG Coated Microparticles, one bottle of Anti- B- hCG Alkaline Phosphatase Conjugate and one bottle of Specimen Diluent. REF Terminated |
JHI | None listed |
| Jul 12, 2007 | Abbott Diagnostic International, Ltd. IMx Total B-hCG Reagent is composed of one bottle of Anti B-hCG Coated Microparticles, one bottle of Anti B-hCG Alkaline Phosphatase Conjungate, one bottle of 4-Methylumbelliferyl Phosphate and one bo Terminated |
JHI | None listed |
| Jul 12, 2007 | Abbott Diagnostic International, Ltd. Total B-hCG Speciment Diluent is composed of 1 bottle of Total B-hCG Specimen Diluent containing animal serum. Terminated |
JHI | None listed |
| Jun 16, 2005 | Abbott Health Products, Inc. AxSYM total B-hCG Reagent is composed of one bottle of Coated Microparticles, one bottle of Alkaline Phosphatase Conjugate and one bottle of Specimen Diluent. Terminated |
JHI | None listed |
| Oct 5, 2004 | Abbott Health Products, Inc. AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21 Terminated |
JHI | None listed |
| Sep 2, 2004 | Abbott Health Products, Inc. AxSYM Total B-hCG Reagent Pack Terminated |
JHI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.