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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
Sep 30, 2011K110904RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3
Randox Laboratories, Ltd., GB
JJY
Sep 14, 2011K111996ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2
Elitechgroup
JJY
Jul 8, 2011K111506ELECSYS PRECICONTROL VARIA 3
Roche Diagnostics
JJY
Jul 5, 2011K110880VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT
Maine Standards Company, LLC
JJY
Jun 29, 2011K110616THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO
Microgenics Corp.
JJY
Jun 28, 2011K111063VITAL SERUM CONTROLS
Vital Diagnostics (Manufacturing) Ptyltd, AT
JJY
Jun 10, 2011K103601AUDIT MICROCV IMMUNOASSAY LINEARITY SET
Aalto Scientific, Ltd.
JJY
May 6, 2011K103364MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL
Diamond Diagnostics, Inc.
JJY
Jan 25, 2011K103271MSC LIPID CONTROL
Maine Standards Co.
JJY
Jan 14, 2011K101216AUDIT MICROCV PROTEIN LINEARITY SET
Aalto Scientific, Ltd.
JJY
Jan 10, 2011K102617AUDIT MICROCV CARDIAC MARKERS LINEARITY SET
Aalto Scientific, Ltd.
JJY
Dec 21, 2010K102700LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALS
Alere, San Diego, Dba Biosite INcorporated, Dba IN
JJY
Oct 5, 2010K101809FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20
Fujirebio Diagnostics,Inc.
JJY
Sep 14, 2010K100727LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK
Bio-Rad, Diagnostics Grp.
JJY
Sep 3, 2010K100718AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5
Aalto Scientific, Ltd.
JJY
Sep 1, 2010K102016PRECICONTROL CLINCHEM MULTI 1 AND 2
Roche Diagnostics
JJY
Aug 31, 2010K101226AUDIT MICROCV RF/CRP LINEARITY SET
Aalto Scientific, Ltd.
JJY
Aug 27, 2010K102157ELECSYS PRECICONTROL MULTIMARKER
Roche Diagnostics
JJY
Aug 27, 2010K101633NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH
Nova Biomedical Corp.
JJY
Mar 19, 2010K093492MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATOR
Diamond Diagnostics, Inc.
JJY
Mar 10, 2010K093384MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3)
Diamond Diagnostics, Inc.
JJY
Nov 13, 2009K093032TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET
Biosite Incorporated
JJY
Nov 3, 2009K092320ELECSYS PRECICONTROL THYROAB
Roche Diagnostics
JJY
Sep 21, 2009K092051THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158
Microgenics Corp.
JJY
Jul 2, 2009K090541ELECSYS PRECICONTROL UNIVERSAL
Roche Diagnostics
JJY
Jun 25, 2009K091225VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SET
Maine Standards Co.
JJY
Apr 21, 2009K083554CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3
Cliniqa Corporation
JJY
Apr 16, 2009K090475VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402
Maine Standards Co.
JJY
Mar 23, 2009K083891VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901
Maine Standards Co.
JJY
Nov 19, 2008K082714AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET, MODEL K707M-5
Aalto Scientific, Ltd.
JJY
Oct 30, 2008K082717AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5
Aalto Scientific, Ltd.
JJY
Sep 17, 2008K082107CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2
Cliniqa Corporation
JJY
Sep 8, 2008K082036LYPHOCHEK TUMOR MARKET PLUS CONTROL LEVEL 1, 2 AND 3 AND MINIPAK
Bio-Rad Laboratories
JJY
Aug 22, 2008K082067MSC LIPID CONTROL
Maine Standards Co.
JJY
Jun 2, 2008K080973CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC
Cliniqa Corporation
JJY
Jan 24, 2008K073080QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945
Bio-Rad Laboratories
JJY
Dec 11, 2007K072835LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAK
Bio-Rad, Diagnostics Grp.
JJY
Dec 7, 2007K072892TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5
Biosite Incorporated
JJY
Sep 14, 2007K072246VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601
Maine Standards Co.
JJY
Sep 11, 2007K071980DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H
Dade Behring, Inc.
JJY
Jul 3, 2007K071675LIQUICHEK TUMOR MARKER CONTROL
Bio-Rad Laboratories
JJY
Jun 28, 2007K071433SMS GLUCOSE CONTROL, MODEL 2120059
Specialty Medical Supplies
JJY
May 4, 2007K070741CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & 3
Cliniqa Corporation
JJY
Apr 11, 2007K070504AMMONIA/ALCOHOL CONTROL SET
Pointe Scientific, Inc.,
JJY
Mar 19, 2007K070200TDM CONTROL SET, MODEL CAT# 04521536
Roche Diagnostics Corp.
JJY
Mar 13, 2007K070223AUDIT MICROCV LIPIDS LINEARITY SET (LOW)
Aalto Scientific, Ltd.
JJY
Jan 31, 2007K062379COBAS INTEGRA CERULOPLASMIN
Roche Diagnostics Corp.
JJY
Dec 1, 2006K062674MISSION TRINITY B
Diamond Diagnostics, Inc.
JJY
Nov 22, 2006K062593CARDIAC MARKERS CONTROL AND CALIBRATION VERIFICATION CONTROL SET
Compass Bioscience
JJY
Oct 23, 2006K062916CLINIQA LIQUID QC CARDIAC MARKER CONTROL SP, LEVELS 1,2, &3
Cliniqa Corporation
JJY

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