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
121–144 of 673
Cleared Sep 14, 2004
MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA
K042389
Roche Diagnostics Corp.
Chemistry · 12d
Cleared Sep 09, 2004
RANDOX TRI LEVEL CARDIAC CONTROL
K041361
Randox Laboratories Limited
Chemistry · 111d
Cleared Jul 27, 2004
MODIFICATION TO ROCHE DIAGNOSTICS PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PROTEINS IN URINE/CSF (PUC)
K041812
Roche Diagnostics Corp.
Chemistry · 21d
Cleared Jul 06, 2004
TRIAGE PROFILER S.O.B. CONTROLS AND S.O.B. CALIBRATION VERIFICATION CONTROLS
K040459
Biosite Incorporated
Chemistry · 134d
Cleared Jun 16, 2004
RANDOX IMMUNOASSAY CONTROL
K040379
Randox Laboratories, Ltd.
Chemistry · 120d
Cleared May 27, 2004
MODIFICATION TO:ROCHE DIAGNOSTICS PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA
K041227
Roche Diagnostics Corp.
Chemistry · 17d
Cleared May 21, 2004
DOCUMENT SALICYLATE CAL VER
K041073
Microgenics Corp.
Chemistry · 25d
Cleared May 19, 2004
LIQUICHEK TORCH PLUS IGM CONTROL
K040822
Bio-Rad Laboratories, Inc.
Microbiology · 50d
Cleared Apr 28, 2004
MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3
K040880
Medical Analysis Systems, Inc.
Chemistry · 23d
Cleared Apr 28, 2004
NORMAL AND HYPERGAMMA CONTROL SERUM
K040925
Sebia
Immunology · 20d
Cleared Mar 29, 2004
LINICAL ENZYME CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON SYSTEMS
K040535
Cliniqa Corporation
Chemistry · 27d
Cleared Mar 11, 2004
PRECINORM PROTEINS IN URINE/CSF PRECIPATH PROTEINS IN URINE/CSR CONTROLS
K040280
Roche Diagnostics Corp.
Chemistry · 34d
Cleared Mar 10, 2004
LIQUICHEK CARDIAC MARKER CONTROL LT
K040277
Bio-Rad Laboratories, Inc.
Chemistry · 34d
Cleared Mar 04, 2004
LYPHOCHEK ASSAYED CHEMISTRY CONTROL
K040273
Bio-Rad Laboratories, Inc.
Chemistry · 28d
Cleared Feb 23, 2004
LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS
K040091
Cliniqa Corporation
Chemistry · 38d
Cleared Jan 07, 2004
ELECSYS PRECICONTROL MULTIANALYTE
K033937
Roche Diagnostics Corp.
Chemistry · 19d
Cleared Dec 19, 2003
BAYER SPECIAL CHEMISTRY CONTROLS
K033379
Bayer Diagnostics Corp.
Chemistry · 58d
Cleared Dec 02, 2003
QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945
K033387
Bio-Rad
Chemistry · 40d
Cleared Oct 21, 2003
LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON ANALYZERS
K032074
Cliniqa Corporation
Chemistry · 106d
Cleared Oct 10, 2003
LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS
K033162
Cliniqa Corporation
Chemistry · 10d
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