Alpha-1-Lipoprotein, Antigen, Antiserum, Control
FDA product code DER · Class II (moderate risk) · 21 CFR 866.5580 · Immunology
17510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Photec Diagnostics, Inc. 3
- Crestat Diagnostics, Inc. 3
- Roche Diagnostics Corp. 2
- Kamiya Biomedical Co. 2
- Hyland Therapeutic Div., Travenol Laboratories 1
- Ventrex Laboratories, Inc. 1
- Solomon Park Research Laboratories 1
- Eucardio Laboratory, Inc. 1
- Roche Diagnostic Systems, Inc. 1
- Abbott Laboratories 1
- Bayer Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K013249 | Tina-Quant Apolipoprotein VER.2DER · Traditional | Roche Diagnostics Corp. | 11/16/2001SE |
| K000921 | Bayer Advia Ims System; 200 + 3DER · Traditional | Bayer Corp. | 05/18/2000SE |
| K993354 | K-Assay Apo BDER · Traditional | Kamiya Biomedical Co. | 10/28/1999SE |
| K993345 | K-Assay Apo AiDER · Traditional | Kamiya Biomedical Co. | 10/25/1999SE |
| K990594 | Integra Reagent Cassette for Apolipoprotein A-1DER · Traditional | Roche Diagnostics Corp. | 04/14/1999SE |
| K983289 | Apolipoprotein A1DER · Traditional | Abbott Laboratories | 01/29/1999SE |
| K964296 | N-Assay Tia Apo B Test KitDER · Traditional | Crestat Diagnostics, Inc. | 08/01/1997SE |
| K964294 | N-Assay Tia Apo A1/B Multi CalibratorDER · Traditional | Crestat Diagnostics, Inc. | 08/01/1997SE |
| K964292 | N-Assay Tia Apo A1 Test KitDER · Traditional | Crestat Diagnostics, Inc. | 08/01/1997SE |
| K910553 | Roche Apolipoprotein StandardDER · Traditional | Roche Diagnostic Systems, Inc. | 05/08/1991SE |
| K904125 | Uc Imu aDER · Traditional | Eucardio Laboratory, Inc. | 09/24/1990SE |
| K872078 | QC3 Whole Human Serum, Hdl-Cholesterol ControlDER · Traditional | Solomon Park Research Laboratories | 06/18/1987SE |
| K854875 | Apo-Screen Calibrator & Control Set for HDL Apo A1DER · Traditional | Photec Diagnostics, Inc. | 01/24/1986SE |
| K853048 | Apo-Screen Test Set for Hdl-Apolipoptein A-1DER · Traditional | Photec Diagnostics, Inc. | 08/28/1985SE |
| K851649 | Apo A-I Immunoassay Test Set for Apolipoprotein A1DER · Traditional | Photec Diagnostics, Inc. | 06/05/1985SE |
| K840830 | Ventria Apo A-1 ALPHA-1 LipotroteinDER · Traditional | Ventrex Laboratories, Inc. | 05/21/1984SE |
| K802610 | Alert A,Hdl-Apoliporotein a, Test KitDER · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 01/05/1981SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1991-2019 Class II | Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determination of…An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU… | Abbott Laboratories, Inc | 05/16/2018Terminated |