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 Sep 09, 2003
AUDIT MICROCONTROLS MICROFD BNP CONTROL
K032122
Aalto Scientific, Ltd.
Chemistry · 62d
Cleared Sep 05, 2003
N/T PROTEIN CONTROL
K032237
Dade Behring, Inc.
Immunology · 46d
Cleared Aug 28, 2003
ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL
K032453
Bionostics, Inc.
Chemistry · 17d
Cleared Aug 25, 2003
LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A - E FOR BECKMAN COULTER SYNCHRON SYSTEMS
K031921
Cliniqa Corporation
Chemistry · 63d
Cleared Aug 19, 2003
MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL
K032335
Medical Analysis Systems, Inc.
Chemistry · 21d
Cleared Aug 06, 2003
LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY PROTEIN SYSTEMS
K031577
Cliniqa Corporation
Chemistry · 78d
Cleared Jul 30, 2003
ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC
K032089
Roche Diagnostics Corp.
Chemistry · 23d
Cleared Jul 23, 2003
LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU ANALYZERS
K031575
Cliniqa Corporation
Immunology · 64d
Cleared Jun 25, 2003
BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL
K031644
Bayer Healthcare, LLC
Chemistry · 29d
Cleared Jun 16, 2003
RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2
K031101
Hemagen Diagnostics, Inc.
Chemistry · 70d
Cleared May 30, 2003
MAS CARDIOLMMUNE PROBNP LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL 1, 2 AND 3
K031364
Medical Analysis Systems, Inc.
Chemistry · 30d
Cleared Apr 28, 2003
MAS CHEMTRAK H & DADE MONI-TROL H LIQUID ASSAYED CHEMISTRY CONTROL
K030942
Medical Analysis Systems, Inc.
Chemistry · 33d
Cleared Apr 09, 2003
BAYER ADVIA 1650 SPECIAL CHEMISTRY CONTROL
K030801
Bayer Healthcare, LLC
Chemistry · 27d
Cleared Mar 26, 2003
CLINIQA LIQUID QC TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3, AND TRI LEVEL
K030705
Cliniqa Corporation
Chemistry · 20d
Cleared Mar 14, 2003
MAS LIPID LEVEL 1 AND 2
K030679
Medical Analysis Systems, Inc.
Chemistry · 10d
Cleared Mar 13, 2003
LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A-E FOR THE OLYMPUS AU SERIES CHEMISTRY IMMUNO ANALYZERS
K030566
Cliniqa Corporation
Chemistry · 17d
Cleared Jan 28, 2003
LINICAL PROTEIN 5 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY AND IMMAGE PROTEIN SYSTEMS
K030150
Cliniqa Corporation
Chemistry · 13d
Cleared Jan 23, 2003
TRIAGE CARDIAC CONTROLS
K030089
Biosite Incorporated
Chemistry · 13d
Cleared Jan 17, 2003
TRIAGE CARDIAC CALIBRATION VERIFICATION CONTROLS, TRIAGE CARDIO PROFILER CALIBRATION VERFICICATION CONTROLS
K030088
Biosite Incorporated
Chemistry · 7d
Cleared Dec 19, 2002
MAS CARDIOIMMUNE TL LOW LEVEL LIQUID ASSAYED CARDIAC MARKER CONTROL, DADE CARDIAC TL LOW LEVEL LIQUID ASSAYED CARDIAC MA
K023669
Medical Analysis Systems, Inc.
Chemistry · 49d
Cleared Dec 17, 2002
MAS T-MARKER, LEVEL 1,2 AND 3, DADE SPECIAL-T MARKER, LEVEL 1,2 AND 3
K023867
Medical Analysis Systems, Inc.
Chemistry · 27d
Cleared Dec 06, 2002
LINICAL RF-CRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS
K023661
Cliniqa Corporation
Chemistry · 36d
Cleared Oct 17, 2002
LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR THE BECKMAN-COULTER IMMAGE
K023250
Cliniqa Corporation
Chemistry · 17d
Cleared Oct 02, 2002
LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A - E FOR THE BECKMAN-COULTER IMMAGE
K022867
Cliniqa Corporation
Chemistry · 35d