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, 2013
MULTICHEM IA AND IA PLUS
K132091
Techno-Path Manufacturing , Ltd.
Chemistry · 74d
Cleared Jul 26, 2013
EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM
K131595
Eurotrol B.V.
Chemistry · 53d
Cleared Jun 19, 2013
RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3
K130337
Randox Laboratories Limited
Immunology · 128d
Cleared May 06, 2013
LIQUICHEK PEDIATRIC CONTROL, LEVEL 1
K130963
Bio-Rad Laboratories, Inc.
Chemistry · 28d
Cleared Apr 29, 2013
AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET
K130762
Aalto Scientific, Ltd.
Chemistry · 40d
Cleared Apr 17, 2013
MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS LEVEL 2, MISSION C
K124009
Diamond Diagnostics, Inc.
Chemistry · 111d
Cleared Apr 12, 2013
LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVEL MINIPAK
K130761
Bio-Rad Laboratories
Immunology · 23d
Cleared Mar 08, 2013
FASTPACK CONTROL KIT
K123725
Qualigen, Inc.
Chemistry · 94d
Cleared Mar 01, 2013
LIQUID ASSAYED MULTIQUAL PREMIUM
K130162
Bio-Rad Laboratories
Chemistry · 37d
Cleared Jan 31, 2013
LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL 2, LIQUICHEK SPINAL FLUID CONTROL MINIPAK
K123775
Bio-Rad Laboratories
Chemistry · 52d
Cleared Dec 27, 2012
LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT
K123663
Bio-Rad Laboratories
Chemistry · 29d
Cleared Nov 20, 2012
RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3
K121603
Randox Laboratories, Ltd.
Chemistry · 228d
Cleared Nov 20, 2012
LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 2 MODEL 272, LIQUICHEK ETHA
K123198
Bio-Rad Laboratories
Chemistry · 40d
Cleared Oct 17, 2012
LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY PLUS CONTROL, LEVEL 2 MODEL 268, LIQUICHEK
K122838
Bio-Rad Laboratories
Chemistry · 30d
Cleared Sep 20, 2012
RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3
K113720
Randox Laboratories, Ltd.
Chemistry · 276d
Cleared Aug 31, 2012
THERMO SCIENTIFIC MAS OMNI-CARDIO
K122291
Microgenics Corporation
Chemistry · 31d
Cleared Jul 24, 2012
CONE-TROL LIQUID CHEMISTRY CONTROLS
K121759
Cone Bioproducts
Chemistry · 39d
Cleared Jul 11, 2012
LIQUICHEK URINE CHEMISTRY CONTROL
K121794
Bio-Rad, Diagnostics Grp.
Chemistry · 22d
Cleared Jun 22, 2012
EUROTROL GAS-ISE METABOLITES
K121468
Eurotrol B.V.
Chemistry · 36d
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 Jan 23, 2012
RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3
K110534
Randox Laboratories Limited
Chemistry · 332d
Cleared Dec 01, 2011
RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVEL
K112337
Randox Laboratories, Ltd.
Chemistry · 108d