MSJ · Class I · 21 CFR 862.1475

FDA Product Code MSJ: Apolipoproteins

Leading manufacturers include Beckman Instruments, Inc., Technicon Instruments Corp. and Roche Diagnostic Systems, Inc..

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 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 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 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 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 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 Jul 18, 1986
ICS APOLIPOPROTEIN A-1 REAGENT TEST KIT
K862019
Beckman Instruments, Inc.
Immunology · 51d
Cleared Jul 18, 1986
ICS APOLIPOPROTEIN B REAGENT TEST KIT
K862386
Beckman Instruments, Inc.
Immunology · 24d
Cleared Mar 28, 1986
BIOGRAM APO A1/B
K860629
Bio-Rad
Immunology · 37d
Cleared May 15, 1985
LASER APO A-I TEST APOLIPOPROTEIN A-I REAGENTS
K850638
Behring Diagnostics, Inc.
Chemistry · 85d

About Product Code MSJ - Regulatory Context