Apolipoproteins
FDA product code MSJ · Class I (low risk) · 21 CFR 862.1475 · Clinical Chemistry
50510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Beckman Instruments, Inc. 4
- Atlantic Antibodies 4
- Intl. Diagnostic Laboratories, Ltd. 2
- Roche Diagnostic Systems, Inc. 2
- Medical Analysis Systems, Inc. 2
- Bacton Assay Systems, Inc. 2
- Kallestad Diag, A Div. of Erbamont, Inc. 2
- Technicon Instruments Corp. 2
- Northwest Biotech 2
- Unipath , Ltd. 2
- Tago, Inc. 2
- Orion Corp. 2
- Instrumentation Laboratory CO 2
- Kent Laboratories, Inc. 2
- Reagents Applications, Inc. 1
- Medix Biotech, Inc. 1
- Ventrex Laboratories, Inc. 1
- Photec Diagnostics, Inc. 1
- General Atomics 1
- Iso-Tex Diagnostics 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K072977 | Diazyme Apolipoprotein A-1 AssayMSJ · Traditional | General Atomics | 07/16/2008SE |
| K073488 | Diazyme Apolipoprotein B Assay, Model Dzxxx-X; B Calibrator, Model DzxxxMSJ · Traditional | Diazyme Laboratories | 03/07/2008SE |
| K061377 | Apolipoprotein A1 and Apolipoprotein B Reagents and CalibratorsMSJ · Traditional | Pointe Scientific, Inc., | 03/28/2007SE |
| K063608 | Dimension Vista APOA1 and Apob Flex Reagent Cartridges and Protein 1 Calibrator and…MSJ · Traditional | Dade Behring, Inc. | 02/23/2007SE |
| K992662 | 8 Additional Assays for the Bayer Advia 1650 Chemistry SystemMSJ · Traditional | Bayer Corp. | 02/15/2000SE |
| K970314 | Synchron LX Systems Apolipoprotein (Apoa and Apob) ReagentsMSJ · Traditional | Beckman Instruments, Inc. | 04/21/1997SE |
| K964010 | Immage Immunochemistry System Apolipoprotein A-1 Reagent (Apa)/ Immage Immunochemistry…MSJ · Traditional | Beckman Instruments, Inc. | 02/10/1997SE |
| K931777 | Apo A-1 Chemiluminescence AssayMSJ · Traditional | Nichols Institute | 08/16/1993SE |
| K925702 | Nichols Apo B Chemiluminescence AssayMSJ · Traditional | Nichols Institute Diagnostics | 12/23/1992SE |
| K923087 | Il Test Apolipoprotein A1MSJ · Traditional | Instrumentation Laboratory CO | 10/26/1992SE |
| K923080 | Il Test Apoliporotein B (Apo B)MSJ · Traditional | Instrumentation Laboratory CO | 10/26/1992SE |
| K921795 | Bacton(Tm), Auto-Apo A-1 ReagentMSJ · Traditional | Bacton Assay Systems, Inc. | 06/23/1992SE |
| K921862 | Bacton(Tm), Auto-Apo B ReagentMSJ · Traditional | Bacton Assay Systems, Inc. | 06/22/1992SE |
| K921037 | Apolipoprotein Test SystemMSJ · Traditional | Baxter Diagnostics, Inc. | 05/22/1992SE |
| K914069 | Reflab(Tm) Brand Syst PK Liq Reagent, Apolipop A-1MSJ · Traditional | Medical Analysis Systems, Inc. | 10/02/1991SE |
| K912749 | Reflab(Tm) BR Syst Pack Liq Reag, Apolipoprotein BMSJ · Traditional | Medical Analysis Systems, Inc. | 09/23/1991SE |
| K910552 | Roche Reagent for Apolipoprotein BMSJ · Traditional | Roche Diagnostic Systems, Inc. | 05/07/1991SE |
| K910551 | Roche Reagent for Apolipoprotein A-1MSJ · Traditional | Roche Diagnostic Systems, Inc. | 05/07/1991SE |
| K895277 | Ortho Apo B Elisa Test SystemMSJ · Traditional | Medical Marketing Consultants, Inc. | 09/27/1989SE |
| K893884 | Bacton TM, Basic TM, Apo B ReagentMSJ · Traditional | Catachem, Inc. | 06/21/1989SE |
| K891154 | Spq(Tm) Antibody Reagent Set II for Apo A-I/Apo BMSJ · Traditional | Atlantic Antibodies | 03/16/1989SE |
| K883714 | QM300 Apolipoprotein B Antibody PackMSJ · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 10/19/1988SE |
| K883713 | QM300 Apolipoprotein A-I Antibody PackMSJ · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 10/19/1988SE |
| K883491 | Technicon DPA-1 Apolipoprotein BMSJ · Traditional | Technicon Instruments Corp. | 09/07/1988SE |
| K882620 | Apolipoprotein for the Technicon DPA-1(TM) SystemMSJ · Traditional | Technicon Instruments Corp. | 07/08/1988SE |
| K881898 | Modified Spq(Tm) Test System for Apolipoprotein BMSJ · Traditional | Atlantic Antibodies | 06/14/1988SE |
| K881434 | Heart Check Apolipoprotein A-1MSJ · Traditional | Northwest Biotech | 04/21/1988SE |
| K881433 | Heart Check Apolipoprotein-BMSJ · Traditional | Northwest Biotech | 04/21/1988SE |
| K873864 | Apolipoprotein BMSJ · Traditional | Unipath , Ltd. | 10/13/1987SE |
| K873863 | Apolipoprotein A1MSJ · Traditional | Unipath , Ltd. | 10/13/1987SE |
| K872794 | Medix Biotech Apolipoprotein A-I Test KitMSJ · Traditional | Medix Biotech, Inc. | 09/23/1987SE |
| K872079 | Raichem(Tm) Spia(Tm) Apo A-1 ReagentsMSJ · Traditional | Reagents Applications, Inc. | 06/15/1987SE |
| K870862 | Spq(Tm) Test System for Apolipoprotein AlMSJ · Traditional | Atlantic Antibodies | 03/24/1987SE |
| K870564 | Spq(Tm) Test System for Apolipoprotein BMSJ · Traditional | Atlantic Antibodies | 03/24/1987SE |
| K864228 | Apo B., Immunoturbidimetric AssayMSJ · Traditional | Intl. Diagnostic Laboratories, Ltd. | 03/12/1987SE |
| K864393 | Apolipoprotein A1 (Apo A1) ImmunoturbidimetricMSJ · Traditional | Intl. Diagnostic Laboratories, Ltd. | 01/16/1987SE |
| K861883 | Immunochemical Assay of Apolipoprotein A1MSJ · Traditional | Orion Corp. | 10/29/1986SE |
| K861882 | Immunochemical Assay Apolipoprotein BMSJ · Traditional | Orion Corp. | 10/29/1986SE |
| K862386 | Ics Apolipoprotein B Reagent Test KitMSJ · Traditional | Beckman Instruments, Inc. | 07/18/1986SE |
| K862019 | Ics Apolipoprotein A-1 Reagent Test KitMSJ · Traditional | Beckman Instruments, Inc. | 07/18/1986SE |
| K861919 | Ventrex Apo BMSJ · Traditional | Ventrex Laboratories, Inc. | 06/06/1986SE |
| K860629 | Biogram Apo A1/BMSJ · Traditional | Bio-Rad | 03/28/1986SE |
| K850691 | Antiserum to Human Apolipoprotein A-IMSJ · Traditional | Kent Laboratories, Inc. | 11/01/1985SE |
| K850690 | Antiserum to Human Apolipoprotein BMSJ · Traditional | Kent Laboratories, Inc. | 11/01/1985SE |
| K853174 | Apo-Chrome Immunoassay Test Set for ApolipoproteinMSJ · Traditional | Photec Diagnostics, Inc. | 08/22/1985SE |
| K851641 | Thrombosil Silica Activated PTT Reagent ThromboxilMSJ · Traditional | Ortho Diagnostic Systems, Inc. | 07/23/1985SE |
| K851389 | Apo B Ria KitMSJ · Traditional | Iso-Tex Diagnostics | 07/10/1985SE |
| K850638 | Laser Apo A-I Test Apolipoprotein A-I ReagentsMSJ · Traditional | Behring Diagnostics, Inc. | 05/15/1985SE |
| K834218 | Diffu-Gen Apolipoprotein A-I Radial -MSJ · Traditional | Tago, Inc. | 05/11/1984SE |
| K833129 | Tago Diffu-Gen-Apolipoprotein B-100MSJ · Traditional | Tago, Inc. | 11/21/1983SE |