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
73–96 of 673
Cleared Jul 02, 2009
ELECSYS PRECICONTROL UNIVERSAL
K090541
Roche Diagnostics
Chemistry · 122d
Cleared Jun 25, 2009
VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SET
K091225
Maine Standards Co.
Chemistry · 59d
Cleared Apr 21, 2009
CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3
K083554
Cliniqa Corporation
Chemistry · 141d
Cleared Apr 16, 2009
VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402
K090475
Maine Standards Co.
Chemistry · 51d
Cleared Mar 23, 2009
VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901
K083891
Maine Standards Co.
Chemistry · 84d
Cleared Nov 19, 2008
AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET, MODEL K707M-5
K082714
Aalto Scientific, Ltd.
Chemistry · 63d
Cleared Oct 30, 2008
AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5
K082717
Aalto Scientific, Ltd.
Immunology · 43d
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 Aug 22, 2008
MSC LIPID CONTROL
K082067
Maine Standards Co.
Chemistry · 31d
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 14, 2007
VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601
K072246
Maine Standards Co.
Immunology · 32d
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 Dec 01, 2006
MISSION TRINITY B
K062674
Diamond Diagnostics, Inc.
Chemistry · 84d
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