FDA Product Code
FDA Product Code MSJ — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1475
510(k) Clearances — 50 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K072977 | DIAZYME APOLIPOPROTEIN A-1 ASSAY | General Atomics | 2008-07-16 | Traditional | PDF ↗ |
| K073488 | DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX | Diazyme Laboratories | 2008-03-07 | Traditional | PDF ↗ |
| K061377 | APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS | Pointe Scientific, Inc., | 2007-03-28 | Traditional | PDF ↗ |
| K063608 | DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH | Dade Behring, Inc. | 2007-02-23 | Traditional | PDF ↗ |
| K992662 | 8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM | Bayer Corp. | 2000-02-15 | Traditional | PDF ↗ |
| K970314 | SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS | Beckman Instruments, Inc. | 1997-04-21 | Traditional | PDF ↗ |
| K964010 | IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENT | Beckman Instruments, Inc. | 1997-02-10 | Traditional | PDF ↗ |
| K931777 | APO A-1 CHEMILUMINESCENCE ASSAY | Nichols Institute | 1993-08-16 | Traditional | PDF ↗ |
| K925702 | NICHOLS APO B CHEMILUMINESCENCE ASSAY | Nichols Institute Diagnostics | 1992-12-23 | Traditional | PDF ↗ |
| K923087 | IL TEST APOLIPOPROTEIN A1 | Instrumentation Laboratory CO | 1992-10-26 | Traditional | PDF ↗ |
| K923080 | IL TEST APOLIPOROTEIN B (APO B) | Instrumentation Laboratory CO | 1992-10-26 | Traditional | PDF ↗ |
| K921795 | BACTON(TM), AUTO-APO A-1 REAGENT | Bacton Assay Systems, Inc. | 1992-06-23 | Traditional | PDF ↗ |
| K921862 | BACTON(TM), AUTO-APO B REAGENT | Bacton Assay Systems, Inc. | 1992-06-22 | Traditional | PDF ↗ |
| K921037 | APOLIPOPROTEIN TEST SYSTEM | Baxter Diagnostics, Inc. | 1992-05-22 | Traditional | PDF ↗ |
| K914069 | REFLAB(TM) BRAND SYST PK LIQ REAGENT, APOLIPOP A-1 | Medical Analysis Systems, Inc. | 1991-10-02 | Traditional | PDF ↗ |
| K912749 | REFLAB(TM) BR SYST PACK LIQ REAG, APOLIPOPROTEIN B | Medical Analysis Systems, Inc. | 1991-09-23 | Traditional | PDF ↗ |
| K910552 | ROCHE REAGENT FOR APOLIPOPROTEIN B | Roche Diagnostic Systems, Inc. | 1991-05-07 | Traditional | PDF ↗ |
| K910551 | ROCHE REAGENT FOR APOLIPOPROTEIN A-1 | Roche Diagnostic Systems, Inc. | 1991-05-07 | Traditional | PDF ↗ |
| K895277 | ORTHO APO B ELISA TEST SYSTEM | Medical Marketing Consultants, Inc. | 1989-09-27 | Traditional | PDF ↗ |
| K893884 | BACTON TM, BASIC TM, APO B REAGENT | Catachem, Inc. | 1989-06-21 | Traditional | PDF ↗ |
| K891154 | SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO B | Atlantic Antibodies | 1989-03-16 | Traditional | PDF ↗ |
| K883713 | QM300 APOLIPOPROTEIN A-I ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-10-19 | Traditional | PDF ↗ |
| K883714 | QM300 APOLIPOPROTEIN B ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-10-19 | Traditional | PDF ↗ |
| K883491 | TECHNICON DPA-1 APOLIPOPROTEIN B | Technicon Instruments Corp. | 1988-09-07 | Traditional | PDF ↗ |
| K882620 | APOLIPOPROTEIN FOR THE TECHNICON DPA-1(TM) SYSTEM | Technicon Instruments Corp. | 1988-07-08 | Traditional | PDF ↗ |
| K881898 | MODIFIED SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B | Atlantic Antibodies | 1988-06-14 | Traditional | PDF ↗ |
| K881433 | HEART CHECK APOLIPOPROTEIN-B | Northwest Biotech | 1988-04-21 | Traditional | PDF ↗ |
| K881434 | HEART CHECK APOLIPOPROTEIN A-1 | Northwest Biotech | 1988-04-21 | Traditional | PDF ↗ |
| K873863 | APOLIPOPROTEIN A1 | Unipath , Ltd. | 1987-10-13 | Traditional | PDF ↗ |
| K873864 | APOLIPOPROTEIN B | Unipath , Ltd. | 1987-10-13 | Traditional | PDF ↗ |
| K872794 | MEDIX BIOTECH APOLIPOPROTEIN A-I TEST KIT | Medix Biotech, Inc. | 1987-09-23 | Traditional | PDF ↗ |
| K872079 | RAICHEM(TM) SPIA(TM) APO A-1 REAGENTS | Reagents Applications, Inc. | 1987-06-15 | Traditional | PDF ↗ |
| K870564 | SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B | Atlantic Antibodies | 1987-03-24 | Traditional | PDF ↗ |
| K870862 | SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN AL | Atlantic Antibodies | 1987-03-24 | Traditional | PDF ↗ |
| K864228 | APO B., IMMUNOTURBIDIMETRIC ASSAY | Intl. Diagnostic Laboratories, Ltd. | 1987-03-12 | Traditional | PDF ↗ |
| K864393 | APOLIPOPROTEIN A1 (APO A1) IMMUNOTURBIDIMETRIC | Intl. Diagnostic Laboratories, Ltd. | 1987-01-16 | Traditional | PDF ↗ |
| K861882 | IMMUNOCHEMICAL ASSAY APOLIPOPROTEIN B | Orion Corp. | 1986-10-29 | Traditional | PDF ↗ |
| K861883 | IMMUNOCHEMICAL ASSAY OF APOLIPOPROTEIN A1 | Orion Corp. | 1986-10-29 | Traditional | PDF ↗ |
| K862019 | ICS APOLIPOPROTEIN A-1 REAGENT TEST KIT | Beckman Instruments, Inc. | 1986-07-18 | Traditional | PDF ↗ |
| K862386 | ICS APOLIPOPROTEIN B REAGENT TEST KIT | Beckman Instruments, Inc. | 1986-07-18 | Traditional | PDF ↗ |
| K861919 | VENTREX APO B | Ventrex Laboratories, Inc. | 1986-06-06 | Traditional | PDF ↗ |
| K860629 | BIOGRAM APO A1/B | Bio-Rad | 1986-03-28 | Traditional | PDF ↗ |
| K850690 | ANTISERUM TO HUMAN APOLIPOPROTEIN B | Kent Laboratories, Inc. | 1985-11-01 | Traditional | PDF ↗ |
| K850691 | ANTISERUM TO HUMAN APOLIPOPROTEIN A-I | Kent Laboratories, Inc. | 1985-11-01 | Traditional | PDF ↗ |
| K853174 | APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN | Photec Diagnostics, Inc. | 1985-08-22 | Traditional | PDF ↗ |
| K851641 | THROMBOSIL SILICA ACTIVATED PTT REAGENT THROMBOXIL | Ortho Diagnostic Systems, Inc. | 1985-07-23 | Traditional | PDF ↗ |
| K851389 | APO B RIA KIT | Iso-Tex Diagnostics | 1985-07-10 | Traditional | PDF ↗ |
| K850638 | LASER APO A-I TEST APOLIPOPROTEIN A-I REAGENTS | Behring Diagnostics, Inc. | 1985-05-15 | Traditional | PDF ↗ |
| K834218 | DIFFU-GEN APOLIPOPROTEIN A-I RADIAL - | Tago, Inc. | 1984-05-11 | Traditional | PDF ↗ |
| K833129 | TAGO DIFFU-GEN-APOLIPOPROTEIN B-100 | Tago, Inc. | 1983-11-21 | Traditional | PDF ↗ |
Product code MSJ · Class I · Clinical Chemistry. Data: openFDA.