JJY · Class I · 21 CFR 862.1660

FDA Product Code JJY: Multi-analyte Controls, All Kinds (assayed)

Leading manufacturers include Bio-Rad, Medical Analysis Systems, Inc. and Cliniqa Corporation.

673
Total
673
Cleared
64d
Avg days
1976
Since
673 devices
49–72 of 673
Cleared Sep 17, 2008
CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2
K082107
Cliniqa Corporation
Chemistry · 54d
Cleared Sep 08, 2008
LYPHOCHEK TUMOR MARKET PLUS CONTROL LEVEL 1, 2 AND 3 AND MINIPAK
K082036
Bio-Rad Laboratories
Immunology · 53d
Cleared Jun 02, 2008
CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3
K080973
Cliniqa Corporation
Chemistry · 59d
Cleared Jan 24, 2008
QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945
K073080
Bio-Rad Laboratories
Chemistry · 85d
Cleared Dec 07, 2007
TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5
K072892
Biosite Incorporated
Chemistry · 58d
Cleared Sep 11, 2007
DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H
K071980
Dade Behring, Inc.
Immunology · 55d
Cleared Jul 03, 2007
LIQUICHEK TUMOR MARKER CONTROL
K071675
Bio-Rad Laboratories
Immunology · 14d
Cleared May 04, 2007
CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & 3
K070741
Cliniqa Corporation
Chemistry · 49d
Cleared Apr 11, 2007
AMMONIA/ALCOHOL CONTROL SET
K070504
Pointe Scientific, Inc.,
Chemistry · 49d
Cleared Mar 19, 2007
TDM CONTROL SET, MODEL CAT# 04521536
K070200
Roche Diagnostics Corp.
Chemistry · 56d
Cleared Mar 13, 2007
AUDIT MICROCV LIPIDS LINEARITY SET (LOW)
K070223
Aalto Scientific, Ltd.
Chemistry · 48d
Cleared Jan 31, 2007
COBAS INTEGRA CERULOPLASMIN
K062379
Roche Diagnostics Corp.
Chemistry · 169d
Cleared Oct 23, 2006
CLINIQA LIQUID QC CARDIAC MARKER CONTROL SP, LEVELS 1,2, &3
K062916
Cliniqa Corporation
Chemistry · 25d
Cleared Oct 16, 2006
AUDIT MICROCV IMMUNOASSAY LINEARITY SET
K062668
Aalto Scientific, Ltd.
Chemistry · 38d
Cleared Jul 06, 2006
ADVIA IMS CPSA CONTROL
K061137
Bayer Healthcare, LLC
Immunology · 73d
Cleared May 30, 2006
CARDIOIMMUNE XL CARDIAC MARKER CONTROL
K061196
Microgenics Corp.
Chemistry · 32d
Cleared May 25, 2006
CLINIQA LIQUID QC LIPID CONTROL LEVELS 1 & 2
K061182
Cliniqa Corporation
Chemistry · 28d
Cleared Mar 15, 2006
TDM CONTROL SET
K060429
Roche Diagnostics Corp.
Chemistry · 22d
Cleared Oct 17, 2005
ELECSYS PRECICONTROL BONE
K051543
Roche Diagnostics Corp.
Chemistry · 129d
Cleared Jul 25, 2005
ELECSYS PRECICONTROL UNIVERSAL
K051687
Roche Diagnostics Corp.
Chemistry · 32d
Cleared Jul 06, 2005
ELECSYS CA 19-9 CALCHECK
K051185
Roche Diagnostics Corp.
Immunology · 58d
Cleared Jul 05, 2005
ELECSYS PRECICONTROL ANEMIA
K051517
Roche Diagnostics Corp.
Chemistry · 27d
Cleared Apr 27, 2005
LIQUICHEK CARDIAC MARKERS PLUS CONTROL, LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LIQUICHEK CARDIAC MARKERS PLUS
K050537
Bio-Rad
Chemistry · 56d
Cleared Apr 25, 2005
ROCHE DIAGNOSTICS ELECSYS PRECICONTROL TUMOR
K050387
Roche Diagnostics Corp.
Immunology · 69d