FDA Product Code JJY: Multi-analyte Controls, All Kinds (assayed)
Leading manufacturers include Bio-Rad, Boehringer Mannheim Corp. and Roche Diagnostics Corp..
673
Total
673
Cleared
64d
Avg days
1976
Since
FDA 510(k) Cleared Multi-analyte Controls, All Kinds (assayed) Devices (Product Code JJY)
673 devices
Cleared
Oct 07, 2013
V8 SP NORMAL CONTROL, ABNORMAL CONTROL
Helena Laboratories
Immunology
138d
Cleared
Sep 11, 2007
DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H
Dade Behring, Inc.
Immunology
55d
Cleared
Mar 19, 2007
TDM CONTROL SET, MODEL CAT# 04521536
Roche Diagnostics Corp.
Chemistry
56d
Cleared
Jan 31, 2007
COBAS INTEGRA CERULOPLASMIN
Roche Diagnostics Corp.
Chemistry
169d
Cleared
Mar 15, 2006
TDM CONTROL SET
Roche Diagnostics Corp.
Chemistry
22d
Cleared
Oct 17, 2005
ELECSYS PRECICONTROL BONE
Roche Diagnostics Corp.
Chemistry
129d
Cleared
Jul 25, 2005
ELECSYS PRECICONTROL UNIVERSAL
Roche Diagnostics Corp.
Chemistry
32d
Cleared
Jul 06, 2005
ELECSYS CA 19-9 CALCHECK
Roche Diagnostics Corp.
Immunology
58d
Cleared
Jul 05, 2005
ELECSYS PRECICONTROL ANEMIA
Roche Diagnostics Corp.
Chemistry
27d
Cleared
Apr 27, 2005
LIQUICHEK CARDIAC MARKERS PLUS CONTROL, LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LIQUICHEK CARDIAC MARKERS PLUS
Bio-Rad
Chemistry
56d
Cleared
Apr 25, 2005
ROCHE DIAGNOSTICS ELECSYS PRECICONTROL TUMOR
Roche Diagnostics Corp.
Immunology
69d
Cleared
Mar 24, 2005
QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL
Bio-Rad
Chemistry
22d
Cleared
Jan 07, 2005
LIQUID ASSAYED MULTIQUAL CONTROL
Bio-Rad
Chemistry
49d
Cleared
Nov 05, 2004
QUEST TUMOR MARKER CONTROL, MODEL 955
Bio-Rad
Immunology
24d
Cleared
Oct 07, 2004
LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CONTROL, LEVEL 4, 5
Bio-Rad
Chemistry
41d
Cleared
Sep 14, 2004
MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA
Roche Diagnostics Corp.
Chemistry
12d
Cleared
Jul 27, 2004
MODIFICATION TO ROCHE DIAGNOSTICS PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PROTEINS IN URINE/CSF (PUC)
Roche Diagnostics Corp.
Chemistry
21d
Cleared
May 27, 2004
MODIFICATION TO:ROCHE DIAGNOSTICS PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA
Roche Diagnostics Corp.
Chemistry
17d
Cleared
Mar 11, 2004
PRECINORM PROTEINS IN URINE/CSF PRECIPATH PROTEINS IN URINE/CSR CONTROLS
Roche Diagnostics Corp.
Chemistry
34d
Cleared
Jan 07, 2004
ELECSYS PRECICONTROL MULTIANALYTE
Roche Diagnostics Corp.
Chemistry
19d
Cleared
Dec 02, 2003
QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945
Bio-Rad
Chemistry
40d
Cleared
Sep 05, 2003
N/T PROTEIN CONTROL
Dade Behring, Inc.
Immunology
46d
Cleared
Jul 30, 2003
ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC
Roche Diagnostics Corp.
Chemistry
23d
Cleared
Sep 17, 2002
LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, AND 3-1 ML, MODEL 591, 592, 593
Bio-Rad
Immunology
8d