MSJ · Class I · 21 CFR 862.1475

FDA Product Code MSJ: Apolipoproteins

Leading manufacturers include Beckman Instruments, Inc., Atlantic Antibodies and Unipath , Ltd..

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 Jul 16, 2008
DIAZYME APOLIPOPROTEIN A-1 ASSAY
K072977
General Atomics
Chemistry · 268d
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 Mar 16, 1989
SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO B
K891154
Atlantic Antibodies
Immunology · 10d
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 Jun 14, 1988
MODIFIED SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B
K881898
Atlantic Antibodies
Immunology · 47d
Cleared Oct 13, 1987
APOLIPOPROTEIN A1
K873863
Unipath , Ltd.
Immunology · 50d
Cleared Oct 13, 1987
APOLIPOPROTEIN B
K873864
Unipath , Ltd.
Immunology · 50d

About Product Code MSJ - Regulatory Context