Company
Abbott Health Products, Inc.
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
15recalls (0 in 12 months)
11recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | 4 |
| 91 | 3 | |
| LOL | Hepatitis A Test (Antibody And Igm Antibody) | 2 |
| DJG | Enzyme Immunoassay, Opiates | 1 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 |
| LDM | Instrumentation, High Pressure Liquid Chromatography | 1 |
| LFG | Radioimmunoassay, Tricyclic Antidepressant Drugs | 1 |
| LFH | U.V. Spectrometry, Tricyclic Antidepressant Drugs | 1 |
| MGU | Fluorescence Polarization Immunoassay For Cyclosporine | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 15, 2006 | Abbott Health Products, Inc. In vitro Test TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Reagent Pack 100 test
TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Calibrators are composed of six vials of calibrators A, B, C, D, E, Terminated |
MGU | None listed |
| 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 | K912535 |
| 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 | K935673 |
| Mar 29, 2005 | Abbott Health Products, Inc. IMx HAVAB Controls In Vitro Test Terminated |
LOL | None listed |
| Nov 20, 2004 | Abbott Health Products, Inc. IMx HAVAB Controls are for In Vitro Diagnostic use. The kit is composed of 2 bottles of Negative and Positive controls of 9 mL each. These are prepared with recalcified human plasma and the preservati Terminated |
LOL | None listed |
| Oct 5, 2004 | Abbott Health Products, Inc. AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21 Terminated |
JHI | K935673 |
| Sep 2, 2004 | Abbott Health Products, Inc. AxSYM Total B-hCG Reagent Pack Terminated |
JHI | K935673 |
| Jul 28, 2004 | Abbott Health Products, Inc. TDx/TDxFLx Opiates Reagent, Product list number: 9673-60 Terminated |
DJG | K874485 |
| Jan 10, 2004 | Abbott Health Products, Inc. TDx/TDxFLx Tricyclic Antidepressants Reagent. Distributed under the following label: TDx/TDxFLx Antidepressants Reagents, Abbott Laboratories USA, North Chicago, IL 60064. Terminated |
LFG | K853113 |
| Jan 10, 2004 | Abbott Health Products, Inc. ADx Tricyclic Antidepressants Reagent. Distributed under the following label: ADx Tricyclic Antidepressants Reagents, Abbott Laboratories USA, North Chicago, IL 60064 Terminated |
LFH | K833113 |
| Jan 10, 2004 | Abbott Health Products, Inc. AxSYM Tricyclic Antidepressants Reagent, Distributed under the following label: AxSYM Tricyclic Antidepressants Reagents, Abbott Laboratories USA, North Chicago, IL 60064 Terminated |
LDM | K953761 |
| Mar 29, 2003 | Abbott Health Products, Inc. TDx/TDxFLx
TDx/TDxFLX Tricyclic Antidepressant Reagent
Distributed under the following label:
TDx/TDxFLX, Abbott Laboratories USA, North Chicago, IL 60064 Terminated |
91 | K853113 |
| Mar 29, 2003 | Abbott Health Products, Inc. ADx Tricyclic Antidepressants Reagent.
Distributed under the following label:
ADx, Abbott Laboratories USA, North Chicago, IL 60064 Terminated |
91 | K833113 |
| Mar 29, 2003 | Abbott Health Products, Inc. AxSYM Tricyclic Antidpressants Reagent. Distributied under the following label:
AxSYM
Abbott Laboratories USA, North Chicago, IL 60064 Terminated |
91 | K953761 |
| Mar 6, 2003 | Abbott Health Products, Inc. AFP Control Kit distributed under the following label:
AxSYM and IMx, Abbott Laboratories USA, North
Chicago, IL 60064 Terminated |
JJE | None listed |