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
97–120 of 673
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 21, 2006
MISSION COMPLETE
K060206
Diamond Diagnostics, Inc.
Chemistry · 54d
Cleared Mar 15, 2006
TDM CONTROL SET
K060429
Roche Diagnostics Corp.
Chemistry · 22d
Cleared Jan 13, 2006
VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET
K053247
Maine Standards Co.
Chemistry · 53d
Cleared Oct 17, 2005
ELECSYS PRECICONTROL BONE
K051543
Roche Diagnostics Corp.
Chemistry · 129d
Cleared Oct 12, 2005
AUTOCHECK6+
K051928
Radiometer Medical Aps
Chemistry · 86d
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
Cleared Mar 25, 2005
VALIDATE URINE CHEMISTRY CALIBRATION VERIFICATION TEST SETS
K050504
Maine Standards Co.
Chemistry · 25d
Cleared Mar 24, 2005
QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL
K050536
Bio-Rad
Chemistry · 22d
Cleared Mar 18, 2005
RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4
K050125
More Diagnostics
Toxicology · 58d
Cleared Jan 07, 2005
LIQUID ASSAYED MULTIQUAL CONTROL
K043208
Bio-Rad
Chemistry · 49d
Cleared Dec 09, 2004
AUDIT MICROCV GENERAL CHEMISTRY LINEARITY SET
K042318
Aalto Scientific, Ltd.
Chemistry · 105d
Cleared Dec 07, 2004
LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL
K043108
Bio-Rad Laboratories, Inc.
Immunology · 28d
Cleared Nov 18, 2004
QUIKREAD CRP CALIBRATOR SET
K042625
Orion Diagnostica, OY
Chemistry · 52d
Cleared Nov 05, 2004
QUEST TUMOR MARKER CONTROL, MODEL 955
K042815
Bio-Rad
Immunology · 24d
Cleared Oct 15, 2004
VALIDATE LIPOPROTEIN CALIBRATION VERIFICATION TEST SET, MODEL 501
K041975
Maine Standards Co.
Chemistry · 85d
Cleared Oct 07, 2004
LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CONTROL, LEVEL 4, 5
K042324
Bio-Rad
Chemistry · 41d
Cleared Sep 17, 2004
ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05
K042335
Bio-Rad Laboratories, Inc.
Immunology · 18d