Product code MSJ
- Device name
- Apolipoproteins
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1475
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K072977 | DIAZYME APOLIPOPROTEIN A-1 ASSAY | General Atomics | 2008-07-16 |
| K073488 | DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX | Diazyme Laboratories | 2008-03-07 |
| K061377 | APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS | Pointe Scientific, Inc., | 2007-03-28 |
| K063608 | DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH | Dade Behring, Inc. | 2007-02-23 |
| K992662 | 8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM | Bayer Corp. | 2000-02-15 |
| K970314 | SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS | Beckman Instruments, Inc. | 1997-04-21 |
| K964010 | IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENT | Beckman Instruments, Inc. | 1997-02-10 |
| K931777 | APO A-1 CHEMILUMINESCENCE ASSAY | Nichols Institute | 1993-08-16 |
| K925702 | NICHOLS APO B CHEMILUMINESCENCE ASSAY | Nichols Institute Diagnostics | 1992-12-23 |
| K923087 | IL TEST APOLIPOPROTEIN A1 | Instrumentation Laboratory CO | 1992-10-26 |
| K923080 | IL TEST APOLIPOROTEIN B (APO B) | Instrumentation Laboratory CO | 1992-10-26 |
| K921795 | BACTON(TM), AUTO-APO A-1 REAGENT | Bacton Assay Systems, Inc. | 1992-06-23 |
| K921862 | BACTON(TM), AUTO-APO B REAGENT | Bacton Assay Systems, Inc. | 1992-06-22 |
| K921037 | APOLIPOPROTEIN TEST SYSTEM | Baxter Diagnostics, Inc. | 1992-05-22 |
| K914069 | REFLAB(TM) BRAND SYST PK LIQ REAGENT, APOLIPOP A-1 | Medical Analysis Systems, Inc. | 1991-10-02 |
| K912749 | REFLAB(TM) BR SYST PACK LIQ REAG, APOLIPOPROTEIN B | Medical Analysis Systems, Inc. | 1991-09-23 |
| K910551 | ROCHE REAGENT FOR APOLIPOPROTEIN A-1 | Roche Diagnostic Systems, Inc. | 1991-05-07 |
| K910552 | ROCHE REAGENT FOR APOLIPOPROTEIN B | Roche Diagnostic Systems, Inc. | 1991-05-07 |
| K895277 | ORTHO APO B ELISA TEST SYSTEM | Medical Marketing Consultants, Inc. | 1989-09-27 |
| K893884 | BACTON TM, BASIC TM, APO B REAGENT | Catachem, Inc. | 1989-06-21 |
| K891154 | SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO B | Atlantic Antibodies | 1989-03-16 |
| K883713 | QM300 APOLIPOPROTEIN A-I ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-10-19 |
| K883714 | QM300 APOLIPOPROTEIN B ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-10-19 |
| K883491 | TECHNICON DPA-1 APOLIPOPROTEIN B | Technicon Instruments Corp. | 1988-09-07 |
| K882620 | APOLIPOPROTEIN FOR THE TECHNICON DPA-1(TM) SYSTEM | Technicon Instruments Corp. | 1988-07-08 |
| K881898 | MODIFIED SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B | Atlantic Antibodies | 1988-06-14 |
| K881433 | HEART CHECK APOLIPOPROTEIN-B | Northwest Biotech | 1988-04-21 |
| K881434 | HEART CHECK APOLIPOPROTEIN A-1 | Northwest Biotech | 1988-04-21 |
| K873863 | APOLIPOPROTEIN A1 | Unipath , Ltd. | 1987-10-13 |
| K873864 | APOLIPOPROTEIN B | Unipath , Ltd. | 1987-10-13 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00817089022478 | Diazyme | DIAZYME LABORATORIES, INC. | 2026-01-21 |
| 06971674866664 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-22 |
| 06971674866671 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-22 |
| 06971674866688 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-22 |
| 06971674867920 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-22 |
| 06971674868255 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-22 |
| 06971674860969 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674860891 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674860907 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674860914 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674860921 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674860938 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674860945 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674860952 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674860853 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674860976 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674860983 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674860990 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674860884 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674860877 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674860860 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674860846 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674860839 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674860822 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674860815 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674860808 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674860792 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674860785 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674860778 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 00817089020863 | Diazyme | DIAZYME LABORATORIES, INC. | 2016-11-03 |