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
25–48 of 673
Cleared Sep 20, 2012
RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3
K113720
Randox Laboratories, Ltd.
Chemistry · 276d
Cleared Jun 15, 2012
AUDIT MICROLQ SPINAL FLUID CONTROL
K112742
Aalto Scientific, Ltd.
Chemistry · 268d
Cleared Mar 02, 2012
AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY
K111964
Aalto Scientific, Ltd.
Chemistry · 235d
Cleared Jan 24, 2012
AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL
K112705
Aalto Scientific, Ltd.
Immunology · 130d
Cleared Dec 01, 2011
RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVEL
K112337
Randox Laboratories, Ltd.
Chemistry · 108d
Cleared Sep 30, 2011
RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3
K110904
Randox Laboratories, Ltd.
Chemistry · 183d
Cleared Jul 08, 2011
ELECSYS PRECICONTROL VARIA 3
K111506
Roche Diagnostics
Chemistry · 37d
Cleared Jun 29, 2011
THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO
K110616
Microgenics Corp.
Chemistry · 118d
Cleared Jun 10, 2011
AUDIT MICROCV IMMUNOASSAY LINEARITY SET
K103601
Aalto Scientific, Ltd.
Chemistry · 184d
Cleared Jan 14, 2011
AUDIT MICROCV PROTEIN LINEARITY SET
K101216
Aalto Scientific, Ltd.
Chemistry · 259d
Cleared Jan 10, 2011
AUDIT MICROCV CARDIAC MARKERS LINEARITY SET
K102617
Aalto Scientific, Ltd.
Chemistry · 122d
Cleared Oct 05, 2010
FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20
K101809
Fujirebio Diagnostics,Inc.
Immunology · 98d
Cleared Sep 03, 2010
AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5
K100718
Aalto Scientific, Ltd.
Chemistry · 175d
Cleared Sep 01, 2010
PRECICONTROL CLINCHEM MULTI 1 AND 2
K102016
Roche Diagnostics
Chemistry · 44d
Cleared Aug 31, 2010
AUDIT MICROCV RF/CRP LINEARITY SET
K101226
Aalto Scientific, Ltd.
Immunology · 120d
Cleared Aug 27, 2010
NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH
K101633
Nova Biomedical Corp.
Chemistry · 78d
Cleared Aug 27, 2010
ELECSYS PRECICONTROL MULTIMARKER
K102157
Roche Diagnostics
Chemistry · 28d
Cleared Nov 13, 2009
TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET
K093032
Biosite Incorporated
Chemistry · 45d
Cleared Nov 03, 2009
ELECSYS PRECICONTROL THYROAB
K092320
Roche Diagnostics
Chemistry · 91d
Cleared Sep 21, 2009
THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158
K092051
Microgenics Corp.
Chemistry · 76d
Cleared Jul 02, 2009
ELECSYS PRECICONTROL UNIVERSAL
K090541
Roche Diagnostics
Chemistry · 122d
Cleared Apr 21, 2009
CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3
K083554
Cliniqa Corporation
Chemistry · 141d
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