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Panels › Clinical Chemistry › Product code JJY · Class 1

Multi-Analyte Controls, All Kinds (Assayed)

Regulation 862.1660

0510(k)s in 12 months (673 all time)
2recalls in 12 months (95 all time)
73recalls that name a 510(k)
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Top companies in JJY

Company510(k)sRecalls
Bio-Rad610
Randox Laboratories Limited1531
Medical Analysis Systems, Inc.310
Bio-Rad Laboratories261
Roche Diagnostics224
Cliniqa Corporation220
Aalto Scientific, Ltd.190
Maine Standards Co.190
Boehringer Mannheim Corp.170
Casco Standards150
Decided510(k)Device and applicantCode
Mar 31, 2017K162530Multichem IA Plus
Techno-Path Manufacturing, IE
JJY
Mar 10, 2017K163629Audit MicroControls Linearity FD Tumor Markers II
Aalto Scientific, Ltd.
JJY
Jan 10, 2017K163015Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3;
Bio-Rad Laboratories
JJY
Jan 28, 2016K153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit
Radiometer America, Inc.
JJY
Dec 11, 2015K150300Liquichek Cardiac Markers Plus Control LT
Bio-Rad Laboratories
JJY
Apr 30, 2015K142964VALIDATE Anemia Calibration Verification/ Linearity Test Kit
Maine Standards Company, LLC
JJY
Mar 13, 2015K143379Liquichek Maternal Serum II Control
Bio-Rad Laboratories
JJY
Jan 16, 2015K143573Audit MicroControls Linearity FD Tumor Markers II
Aalto Scientific, Ltd.
JJY
Dec 8, 2014K140971LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3.
Randox Laboratories Limited, GB
JJY
Nov 20, 2014K142978Audit MicroControls Linearity LQ Special Diabetes
Aalto Scientific, Ltd.
JJY
Jul 11, 2014K133676ABX PENTRA MICRO ALB CONTROL L/H
HORIBA ABX SAS, FR
JJY
Jun 23, 2014K141073LIQUICHEK TUMOR MARKER CONTROL
Bio-Rad Laboratories
JJY
May 22, 2014K140522RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL
Randox Laboratories Limited, GB
JJY
May 6, 2014K140916LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK
Bio-Rad Laboratories
JJY
Apr 25, 2014K140764LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAK
Bio-Rad Laboratories
JJY
Apr 24, 2014K134013LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGATIVE MINIPAK, LYPHOCHEK ALLERGEN SIGE CO
Bio-Rad Laboratories
JJY
Mar 25, 2014K140393RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3
Randox Laboratories Limited, GB
JJY
Jan 22, 2014K133960LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL
Bio-Rad Laboratories
JJY
Oct 25, 2013K132227LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAY
Bio-Rad Laboratories
JJY
Oct 23, 2013K132156RANDOX CSF CONTROLS LEVELS 2 AND 3
Randox Laboratories, Ltd., GB
JJY
Oct 22, 2013K132751MULTICHEM S PLUS / S PLUS (ASSAYED)
Techno-Path Manufacturing , Ltd.
JJY
Oct 15, 2013K131993MULTICHEM U
Techno-Path Manufacturing , Ltd.
JJY
Oct 7, 2013K131479V8 SP NORMAL CONTROL, ABNORMAL CONTROL
Helena Laboratories
JJY
Sep 25, 2013K131992MULTICHEM P
Techno-Path Manufacturing , Ltd.
JJY
Sep 20, 2013K132091MULTICHEM IA AND IA PLUS
Techno-Path Manufacturing , Ltd.
JJY
Jul 26, 2013K131595EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM
Eurotrol B.V., NL
JJY
Jun 19, 2013K130337RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3
Randox Laboratories Limited, GB
JJY
May 6, 2013K130963LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK
Bio-Rad Laboratories, Inc.
JJY
Apr 29, 2013K130762AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET
Aalto Scientific, Ltd.
JJY
Apr 17, 2013K124009MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS LEVEL 2, MISSION C
Diamond Diagnostics, Inc.
JJY
Apr 12, 2013K130761LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVEL MINIPAK
Bio-Rad Laboratories
JJY
Mar 8, 2013K123725FASTPACK CONTROL KIT
Qualigen, Inc.
JJY
Mar 1, 2013K130162LIQUID ASSAYED MULTIQUAL PREMIUM
Bio-Rad Laboratories
JJY
Jan 31, 2013K123775LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL 2, LIQUICHEK SPINAL FLUID CONTROL MINIPAK
Bio-Rad Laboratories
JJY
Dec 27, 2012K123663LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK
Bio-Rad Laboratories
JJY
Nov 20, 2012K123198LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 2 MODEL 272, LIQUICHEK ETHA
Bio-Rad Laboratories
JJY
Nov 20, 2012K121603RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3
Randox Laboratories, Ltd., GB
JJY
Oct 17, 2012K122838LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY PLUS CONTROL, LEVEL 2 MODEL 268, LIQUICHEK
Bio-Rad Laboratories
JJY
Sep 20, 2012K113720RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3
Randox Laboratories, Ltd., GB
JJY
Aug 31, 2012K122291THERMO SCIENTIFIC MAS OMNI-CARDIO
Microgenics Corporation
JJY
Jul 24, 2012K121759CONE-TROL LIQUID CHEMISTRY CONTROLS
Cone Bioproducts
JJY
Jul 11, 2012K121794LIQUICHEK URINE CHEMISTRY CONTROL
Bio-Rad, Diagnostics Grp.
JJY
Jun 22, 2012K121468EUROTROL GAS-ISE METABOLITES
Eurotrol B.V., NL
JJY
Jun 15, 2012K112742AUDIT MICROLQ SPINAL FLUID CONTROL
Aalto Scientific, Ltd.
JJY
Mar 2, 2012K111964AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY
Aalto Scientific, Ltd.
JJY
Jan 24, 2012K112705AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL
Aalto Scientific, Ltd.
JJY
Jan 23, 2012K110534RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3
Randox Laboratories Limited, GB
JJY
Dec 1, 2011K112337RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVEL
Randox Laboratories, Ltd., GB
JJY
Nov 7, 2011K101863IT/IF CONTROL
Sebia
JJY
Nov 3, 2011K110738THERMO SCIENTIFIC MAS OMNI-CORE
Microgenics Corporation
JJY

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