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 Mar 24, 2005
QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL
K050536
Bio-Rad
Chemistry · 22d
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 05, 2004
QUEST TUMOR MARKER CONTROL, MODEL 955
K042815
Bio-Rad
Immunology · 24d
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
Cleared Sep 14, 2004
MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA
K042389
Roche Diagnostics Corp.
Chemistry · 12d
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 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 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