Panels › Clinical Chemistry › Product code MSJ · Class 1
Apolipoproteins
Regulation 862.1475
0510(k)s in 12 months (50 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in MSJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Atlantic Antibodies | 4 | 0 |
| Beckman Instruments, Inc. | 4 | 0 |
| Bacton Assay Systems, Inc. | 2 | 0 |
| Instrumentation Laboratory CO | 2 | 0 |
| Intl. Diagnostic Laboratories, Ltd. | 2 | 0 |
| Kallestad Diag, A Div. of Erbamont, Inc. | 2 | 0 |
| Kent Laboratories, Inc. | 2 | 0 |
| Medical Analysis Systems, Inc. | 2 | 0 |
| Northwest Biotech | 2 | 0 |
| Orion Corp. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 16, 2008 | K072977 | DIAZYME APOLIPOPROTEIN A-1 ASSAY General Atomics | MSJ |
| Mar 7, 2008 | K073488 | DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX Diazyme Laboratories | MSJ |
| Mar 28, 2007 | K061377 | APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS Pointe Scientific, Inc., | MSJ |
| Feb 23, 2007 | K063608 | DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH Dade Behring, Inc. | MSJ |
| Feb 15, 2000 | K992662 | 8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM Bayer Corp. | MSJ |
| Apr 21, 1997 | K970314 | SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS Beckman Instruments, Inc. | MSJ |
| Feb 10, 1997 | K964010 | IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENT Beckman Instruments, Inc. | MSJ |
| Aug 16, 1993 | K931777 | APO A-1 CHEMILUMINESCENCE ASSAY Nichols Institute | MSJ |
| Dec 23, 1992 | K925702 | NICHOLS APO B CHEMILUMINESCENCE ASSAY Nichols Institute Diagnostics | MSJ |
| Oct 26, 1992 | K923087 | IL TEST APOLIPOPROTEIN A1 Instrumentation Laboratory CO | MSJ |
| Oct 26, 1992 | K923080 | IL TEST APOLIPOROTEIN B (APO B) Instrumentation Laboratory CO | MSJ |
| Jun 23, 1992 | K921795 | BACTON(TM), AUTO-APO A-1 REAGENT Bacton Assay Systems, Inc. | MSJ |
| Jun 22, 1992 | K921862 | BACTON(TM), AUTO-APO B REAGENT Bacton Assay Systems, Inc. | MSJ |
| May 22, 1992 | K921037 | APOLIPOPROTEIN TEST SYSTEM Baxter Diagnostics, Inc. | MSJ |
| Oct 2, 1991 | K914069 | REFLAB(TM) BRAND SYST PK LIQ REAGENT, APOLIPOP A-1 Medical Analysis Systems, Inc. | MSJ |
| Sep 23, 1991 | K912749 | REFLAB(TM) BR SYST PACK LIQ REAG, APOLIPOPROTEIN B Medical Analysis Systems, Inc. | MSJ |
| May 7, 1991 | K910552 | ROCHE REAGENT FOR APOLIPOPROTEIN B Roche Diagnostic Systems, Inc. | MSJ |
| May 7, 1991 | K910551 | ROCHE REAGENT FOR APOLIPOPROTEIN A-1 Roche Diagnostic Systems, Inc. | MSJ |
| Sep 27, 1989 | K895277 | ORTHO APO B ELISA TEST SYSTEM Medical Marketing Consultants, Inc. | MSJ |
| Jun 21, 1989 | K893884 | BACTON TM, BASIC TM, APO B REAGENT Catachem, Inc. | MSJ |
| Mar 16, 1989 | K891154 | SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO B Atlantic Antibodies | MSJ |
| Oct 19, 1988 | K883714 | QM300 APOLIPOPROTEIN B ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. | MSJ |
| Oct 19, 1988 | K883713 | QM300 APOLIPOPROTEIN A-I ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. | MSJ |
| Sep 7, 1988 | K883491 | TECHNICON DPA-1 APOLIPOPROTEIN B Technicon Instruments Corp. | MSJ |
| Jul 8, 1988 | K882620 | APOLIPOPROTEIN FOR THE TECHNICON DPA-1(TM) SYSTEM Technicon Instruments Corp. | MSJ |
| Jun 14, 1988 | K881898 | MODIFIED SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B Atlantic Antibodies | MSJ |
| Apr 21, 1988 | K881434 | HEART CHECK APOLIPOPROTEIN A-1 Northwest Biotech | MSJ |
| Apr 21, 1988 | K881433 | HEART CHECK APOLIPOPROTEIN-B Northwest Biotech | MSJ |
| Oct 13, 1987 | K873864 | APOLIPOPROTEIN B Unipath , Ltd., GB | MSJ |
| Oct 13, 1987 | K873863 | APOLIPOPROTEIN A1 Unipath , Ltd., GB | MSJ |
| Sep 23, 1987 | K872794 | MEDIX BIOTECH APOLIPOPROTEIN A-I TEST KIT Medix Biotech, Inc. | MSJ |
| Jun 15, 1987 | K872079 | RAICHEM(TM) SPIA(TM) APO A-1 REAGENTS Reagents Applications, Inc. | MSJ |
| Mar 24, 1987 | K870862 | SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN AL Atlantic Antibodies | MSJ |
| Mar 24, 1987 | K870564 | SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B Atlantic Antibodies | MSJ |
| Mar 12, 1987 | K864228 | APO B., IMMUNOTURBIDIMETRIC ASSAY Intl. Diagnostic Laboratories, Ltd., IL | MSJ |
| Jan 16, 1987 | K864393 | APOLIPOPROTEIN A1 (APO A1) IMMUNOTURBIDIMETRIC Intl. Diagnostic Laboratories, Ltd., IL | MSJ |
| Oct 29, 1986 | K861883 | IMMUNOCHEMICAL ASSAY OF APOLIPOPROTEIN A1 Orion Corp., FI | MSJ |
| Oct 29, 1986 | K861882 | IMMUNOCHEMICAL ASSAY APOLIPOPROTEIN B Orion Corp., FI | MSJ |
| Jul 18, 1986 | K862386 | ICS APOLIPOPROTEIN B REAGENT TEST KIT Beckman Instruments, Inc. | MSJ |
| Jul 18, 1986 | K862019 | ICS APOLIPOPROTEIN A-1 REAGENT TEST KIT Beckman Instruments, Inc. | MSJ |
| Jun 6, 1986 | K861919 | VENTREX APO B Ventrex Laboratories, Inc. | MSJ |
| Mar 28, 1986 | K860629 | BIOGRAM APO A1/B Bio-Rad | MSJ |
| Nov 1, 1985 | K850691 | ANTISERUM TO HUMAN APOLIPOPROTEIN A-I Kent Laboratories, Inc. | MSJ |
| Nov 1, 1985 | K850690 | ANTISERUM TO HUMAN APOLIPOPROTEIN B Kent Laboratories, Inc. | MSJ |
| Aug 22, 1985 | K853174 | APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN Photec Diagnostics, Inc. | MSJ |
| Jul 23, 1985 | K851641 | THROMBOSIL SILICA ACTIVATED PTT REAGENT THROMBOXIL Ortho Diagnostic Systems, Inc. | MSJ |
| Jul 10, 1985 | K851389 | APO B RIA KIT Iso-Tex Diagnostics | MSJ |
| May 15, 1985 | K850638 | LASER APO A-I TEST APOLIPOPROTEIN A-I REAGENTS Behring Diagnostics, Inc. | MSJ |
| May 11, 1984 | K834218 | DIFFU-GEN APOLIPOPROTEIN A-I RADIAL - Tago, Inc. | MSJ |
| Nov 21, 1983 | K833129 | TAGO DIFFU-GEN-APOLIPOPROTEIN B-100 Tago, Inc. | MSJ |
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