MSJ · Class I · 21 CFR 862.1475

FDA Product Code MSJ: Apolipoproteins

Leading manufacturers include Beckman Instruments, Inc., Unipath , Ltd. and Technicon Instruments Corp..

50
Total
50
Cleared
87d
Avg days
1983
Since

FDA 510(k) Cleared Apolipoproteins Devices (Product Code MSJ)

50 devices
1–24 of 50
Cleared Mar 07, 2008
DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X
K073488
Diazyme Laboratories
Chemistry · 137d
Cleared Mar 28, 2007
APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS
K061377
Pointe Scientific, Inc.,
Chemistry · 315d
Cleared Feb 23, 2007
DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH
K063608
Dade Behring, Inc.
Chemistry · 81d
Cleared Feb 15, 2000
8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
K992662
Bayer Corp.
Chemistry · 190d
Cleared Apr 21, 1997
SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS
K970314
Beckman Instruments, Inc.
Chemistry · 87d
Cleared Feb 10, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENT
K964010
Beckman Instruments, Inc.
Immunology · 126d
Cleared Dec 23, 1992
NICHOLS APO B CHEMILUMINESCENCE ASSAY
K925702
Nichols Institute Diagnostics
Immunology · 41d
Cleared Oct 26, 1992
IL TEST APOLIPOROTEIN B (APO B)
K923080
Instrumentation Laboratory CO
Immunology · 123d
Cleared Oct 26, 1992
IL TEST APOLIPOPROTEIN A1
K923087
Instrumentation Laboratory CO
Immunology · 123d
Cleared May 22, 1992
APOLIPOPROTEIN TEST SYSTEM
K921037
Baxter Diagnostics, Inc.
Immunology · 79d
Cleared Oct 02, 1991
REFLAB(TM) BRAND SYST PK LIQ REAGENT, APOLIPOP A-1
K914069
Medical Analysis Systems, Inc.
Immunology · 21d
Cleared Sep 23, 1991
REFLAB(TM) BR SYST PACK LIQ REAG, APOLIPOPROTEIN B
K912749
Medical Analysis Systems, Inc.
Immunology · 94d
Cleared May 07, 1991
ROCHE REAGENT FOR APOLIPOPROTEIN A-1
K910551
Roche Diagnostic Systems, Inc.
Immunology · 89d
Cleared May 07, 1991
ROCHE REAGENT FOR APOLIPOPROTEIN B
K910552
Roche Diagnostic Systems, Inc.
Immunology · 89d
Cleared Jun 21, 1989
BACTON TM, BASIC TM, APO B REAGENT
K893884
Catachem, Inc.
Immunology · 22d
Cleared Oct 19, 1988
QM300 APOLIPOPROTEIN A-I ANTIBODY PACK
K883713
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 50d
Cleared Oct 19, 1988
QM300 APOLIPOPROTEIN B ANTIBODY PACK
K883714
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 50d
Cleared Sep 07, 1988
TECHNICON DPA-1 APOLIPOPROTEIN B
K883491
Technicon Instruments Corp.
Immunology · 22d
Cleared Jul 08, 1988
APOLIPOPROTEIN FOR THE TECHNICON DPA-1(TM) SYSTEM
K882620
Technicon Instruments Corp.
Immunology · 14d
Cleared Oct 13, 1987
APOLIPOPROTEIN A1
K873863
Unipath , Ltd.
Immunology · 50d
Cleared Oct 13, 1987
APOLIPOPROTEIN B
K873864
Unipath , Ltd.
Immunology · 50d
Cleared Sep 23, 1987
MEDIX BIOTECH APOLIPOPROTEIN A-I TEST KIT
K872794
Medix Biotech, Inc.
Immunology · 71d
Cleared Jun 15, 1987
RAICHEM(TM) SPIA(TM) APO A-1 REAGENTS
K872079
Reagents Applications, Inc.
Immunology · 17d
Cleared Jul 18, 1986
ICS APOLIPOPROTEIN A-1 REAGENT TEST KIT
K862019
Beckman Instruments, Inc.
Immunology · 51d

About Product Code MSJ - Regulatory Context