Product Code: MSJ
FDA class 1
21 CFR 862.1475
Apolipoproteins
Clinical Chemistry
An Apolipoproteins test system is a laboratory in vitro diagnostic device used to measure the concentration of specific apolipoproteins in blood, which are protein components of lipoproteins important in lipid metabolism and cardiovascular risk assessment. It is classified as FDA Class 1 under general controls, with product code MSJ and regulation number 21 CFR 862.1475, reviewed by the Clinical Chemistry panel. GMP requirements apply and no premarket submission is required. The device is not an implant and is not life-sustaining.
510(k)s
50
FEI Numbers
21
Registration Numbers
21
Unique Applicants
32
Years Active
25
Research product code MSJ in seconds
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Basic Information
- Product Code
- MSJ
- Device Class
- FDA class 1
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 50 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K072977 | DIAZYME APOLIPOPROTEIN A-1 ASSAY | Jul 16, 2008 | Substantially Equivalent | General Atomics |
| K073488 | DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX | Mar 07, 2008 | Substantially Equivalent | Diazyme Laboratories |
| K061377 | APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS | Mar 28, 2007 | Substantially Equivalent | Pointe Scientific, Inc., |
| K063608 | DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH | Feb 23, 2007 | Substantially Equivalent | Dade Behring, Inc. |
| K992662 | 8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM | Feb 15, 2000 | Substantially Equivalent | Bayer Corp. |
| K970314 | SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS | Apr 21, 1997 | Substantially Equivalent | Beckman Instruments, Inc. |
| K964010 | IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENT | Feb 10, 1997 | Substantially Equivalent | Beckman Instruments, Inc. |
| K931777 | APO A-1 CHEMILUMINESCENCE ASSAY | Aug 16, 1993 | Substantially Equivalent | Nichols Institute |
| K925702 | NICHOLS APO B CHEMILUMINESCENCE ASSAY | Dec 23, 1992 | Substantially Equivalent | Nichols Institute Diagnostics |
| K923087 | IL TEST APOLIPOPROTEIN A1 | Oct 26, 1992 | Substantially Equivalent | Instrumentation Laboratory CO |
| K923080 | IL TEST APOLIPOROTEIN B (APO B) | Oct 26, 1992 | Substantially Equivalent | Instrumentation Laboratory CO |
| K921795 | BACTON(TM), AUTO-APO A-1 REAGENT | Jun 23, 1992 | Substantially Equivalent | Bacton Assay Systems, Inc. |
| K921862 | BACTON(TM), AUTO-APO B REAGENT | Jun 22, 1992 | Substantially Equivalent | Bacton Assay Systems, Inc. |
| K921037 | APOLIPOPROTEIN TEST SYSTEM | May 22, 1992 | Substantially Equivalent | Baxter Diagnostics, Inc. |
| K914069 | REFLAB(TM) BRAND SYST PK LIQ REAGENT, APOLIPOP A-1 | Oct 02, 1991 | Substantially Equivalent | Medical Analysis Systems, Inc. |
| K912749 | REFLAB(TM) BR SYST PACK LIQ REAG, APOLIPOPROTEIN B | Sep 23, 1991 | Substantially Equivalent | Medical Analysis Systems, Inc. |
| K910552 | ROCHE REAGENT FOR APOLIPOPROTEIN B | May 07, 1991 | Substantially Equivalent | Roche Diagnostic Systems, Inc. |
| K910551 | ROCHE REAGENT FOR APOLIPOPROTEIN A-1 | May 07, 1991 | Substantially Equivalent | Roche Diagnostic Systems, Inc. |
| K895277 | ORTHO APO B ELISA TEST SYSTEM | Sep 27, 1989 | Substantially Equivalent | Medical Marketing Consultants, Inc. |
| K893884 | BACTON TM, BASIC TM, APO B REAGENT | Jun 21, 1989 | Substantially Equivalent | Catachem, Inc. |
| K891154 | SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO B | Mar 16, 1989 | Substantially Equivalent | Atlantic Antibodies |
| K883714 | QM300 APOLIPOPROTEIN B ANTIBODY PACK | Oct 19, 1988 | Substantially Equivalent | Kallestad Diag, A Div. of Erbamont, Inc. |
| K883713 | QM300 APOLIPOPROTEIN A-I ANTIBODY PACK | Oct 19, 1988 | Substantially Equivalent | Kallestad Diag, A Div. of Erbamont, Inc. |
| K883491 | TECHNICON DPA-1 APOLIPOPROTEIN B | Sep 07, 1988 | Substantially Equivalent | Technicon Instruments Corp. |
| K882620 | APOLIPOPROTEIN FOR THE TECHNICON DPA-1(TM) SYSTEM | Jul 08, 1988 | Substantially Equivalent | Technicon Instruments Corp. |
| K881898 | MODIFIED SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B | Jun 14, 1988 | Substantially Equivalent | Atlantic Antibodies |
| K881434 | HEART CHECK APOLIPOPROTEIN A-1 | Apr 21, 1988 | Substantially Equivalent | Northwest Biotech |
| K881433 | HEART CHECK APOLIPOPROTEIN-B | Apr 21, 1988 | Substantially Equivalent | Northwest Biotech |
| K873864 | APOLIPOPROTEIN B | Oct 13, 1987 | Substantially Equivalent | Unipath , Ltd. |
| K873863 | APOLIPOPROTEIN A1 | Oct 13, 1987 | Substantially Equivalent | Unipath , Ltd. |
| K872794 | MEDIX BIOTECH APOLIPOPROTEIN A-I TEST KIT | Sep 23, 1987 | Substantially Equivalent | Medix Biotech, Inc. |
| K872079 | RAICHEM(TM) SPIA(TM) APO A-1 REAGENTS | Jun 15, 1987 | Substantially Equivalent | Reagents Applications, Inc. |
| K870862 | SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN AL | Mar 24, 1987 | Substantially Equivalent | Atlantic Antibodies |
| K870564 | SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B | Mar 24, 1987 | Substantially Equivalent | Atlantic Antibodies |
| K864228 | APO B., IMMUNOTURBIDIMETRIC ASSAY | Mar 12, 1987 | Substantially Equivalent | Intl. Diagnostic Laboratories, Ltd. |
| K864393 | APOLIPOPROTEIN A1 (APO A1) IMMUNOTURBIDIMETRIC | Jan 16, 1987 | Substantially Equivalent | Intl. Diagnostic Laboratories, Ltd. |
| K861883 | IMMUNOCHEMICAL ASSAY OF APOLIPOPROTEIN A1 | Oct 29, 1986 | Substantially Equivalent | Orion Corp. |
| K861882 | IMMUNOCHEMICAL ASSAY APOLIPOPROTEIN B | Oct 29, 1986 | Substantially Equivalent | Orion Corp. |
| K862386 | ICS APOLIPOPROTEIN B REAGENT TEST KIT | Jul 18, 1986 | Substantially Equivalent | Beckman Instruments, Inc. |
| K862019 | ICS APOLIPOPROTEIN A-1 REAGENT TEST KIT | Jul 18, 1986 | Substantially Equivalent | Beckman Instruments, Inc. |
| K861919 | VENTREX APO B | Jun 06, 1986 | Substantially Equivalent | Ventrex Laboratories, Inc. |
| K860629 | BIOGRAM APO A1/B | Mar 28, 1986 | Substantially Equivalent | Bio-Rad |
| K850691 | ANTISERUM TO HUMAN APOLIPOPROTEIN A-I | Nov 01, 1985 | Substantially Equivalent | Kent Laboratories, Inc. |
| K850690 | ANTISERUM TO HUMAN APOLIPOPROTEIN B | Nov 01, 1985 | Substantially Equivalent | Kent Laboratories, Inc. |
| K853174 | APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN | Aug 22, 1985 | Substantially Equivalent | Photec Diagnostics, Inc. |
| K851641 | THROMBOSIL SILICA ACTIVATED PTT REAGENT THROMBOXIL | Jul 23, 1985 | Substantially Equivalent | Ortho Diagnostic Systems, Inc. |
| K851389 | APO B RIA KIT | Jul 10, 1985 | Substantially Equivalent | Iso-Tex Diagnostics |
| K850638 | LASER APO A-I TEST APOLIPOPROTEIN A-I REAGENTS | May 15, 1985 | Substantially Equivalent | Behring Diagnostics, Inc. |
| K834218 | DIFFU-GEN APOLIPOPROTEIN A-I RADIAL - | May 11, 1984 | Substantially Equivalent | Tago, Inc. |
| K833129 | TAGO DIFFU-GEN-APOLIPOPROTEIN B-100 | Nov 21, 1983 | Substantially Equivalent | Tago, Inc. |
FEI Numbers
This FDA classification entry is associated with 21 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 21 registration numbers. Click on an entry to view related FDA registrations.