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JJY

673 FDA 510(k) clearances · Product code

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RecordFirmDate
AUDIT MICROCV IMMUNOASSAY LINEARITY SET (K062668)Aalto Scientific, Ltd.2006-10-16
ADVIA IMS CPSA CONTROL (K061137)Bayer Healthcare, LLC2006-07-06
NOD CHEMISTRY CONTROL (K060850)Bioresource Technology, Inc.2006-05-30
CARDIOIMMUNE XL CARDIAC MARKER CONTROL (K061196)Microgenics Corp.2006-05-30
CLINIQA LIQUID QC LIPID CONTROL LEVELS 1 & 2;LINICAL LIPID CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS;QALIB (K061182)Cliniqa Corporation2006-05-25
MISSION COMPLETE (K060206)Diamond Diagnostics, Inc.2006-03-21
TDM CONTROL SET (K060429)Roche Diagnostics Corp.2006-03-15
VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET (K053247)Maine Standards Co.2006-01-13
ELECSYS PRECICONTROL BONE (K051543)Roche Diagnostics Corp.2005-10-17
AUTOCHECK6+ (K051928)Radiometer Medical Aps2005-10-12
DATA-TROL N NORMAL CONTROL SERUM, DATA-TROL A ABNORMAL CONTROL SERUM (K052056)Thermo-Electron Corp.2005-09-23
ELECSYS PRECICONTROL UNIVERSAL (K051687)Roche Diagnostics Corp.2005-07-25
ELECSYS CA 19-9 CALCHECK (K051185)Roche Diagnostics Corp.2005-07-06
ELECSYS PRECICONTROL ANEMIA (K051517)Roche Diagnostics Corp.2005-07-05
LIQUICHEK CARDIAC MARKERS PLUS CONTROL, LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LIQUICHEK CARDIAC MARKERS PLUS (K050537)Bio-Rad2005-04-27
ROCHE DIAGNOSTICS ELECSYS PRECICONTROL TUMOR (K050387)Roche Diagnostics Corp.2005-04-25
VALIDATE URINE CHEMISTRY CALIBRATION VERIFICATION TEST SETS (K050504)Maine Standards Co.2005-03-25
QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL (K050536)Bio-Rad2005-03-24
RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4 (K050125)More Diagnostics2005-03-18
LIQUID ASSAYED MULTIQUAL CONTROL (K043208)Bio-Rad2005-01-07
AUDIT MICROCV GENERAL CHEMISTRY LINEARITY SET (K042318)Aalto Scientific, Ltd.2004-12-09
LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL (K043108)Bio-Rad Laboratories, Inc.2004-12-07
QUIKREAD CRP CALIBRATOR SET (K042625)Orion Diagnostica, OY2004-11-18
QUEST TUMOR MARKER CONTROL, MODEL 955 (K042815)Bio-Rad2004-11-05
VALIDATE LIPOPROTEIN CALIBRATION VERIFICATION TEST SET, MODEL 501 (K041975)Maine Standards Co.2004-10-15
LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CONTROL, LEVEL 4, 5 (K042324)Bio-Rad2004-10-07
ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05; ARCHITECT TITAL PSA MASTERCHECK, MODEL 6C06-05 (K042335)Bio-Rad Laboratories, Inc.2004-09-17
MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA (K042389)Roche Diagnostics Corp.2004-09-14
RANDOX TRI LEVEL CARDIAC CONTROL (K041361)Randox Laboratories Limited2004-09-09
MODIFICATION TO ROCHE DIAGNOSTICS PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PROTEINS IN URINE/CSF (PUC) (K041812)Roche Diagnostics Corp.2004-07-27
TRIAGE PROFILER S.O.B. CONTROLS AND S.O.B. CALIBRATION VERIFICATION CONTROLS (K040459)Biosite Incorporated2004-07-06
RANDOX IMMUNOASSAY CONTROL (K040379)Randox Laboratories, Ltd.2004-06-16
MODIFICATION TO:ROCHE DIAGNOSTICS PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA (K041227)Roche Diagnostics Corp.2004-05-27
DOCUMENT SALICYLATE CAL VER (K041073)Microgenics Corp.2004-05-21
LIQUICHEK TORCH PLUS IGM CONTROL (K040822)Bio-Rad Laboratories, Inc.2004-05-19
NORMAL AND HYPERGAMMA CONTROL SERUM (K040925)Sebia2004-04-28
MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 (K040880)Medical Analysis Systems, Inc.2004-04-28
NOVA-ONE LIPID CONTROL (SPECIAL LOW INTERFERENCE LIQUID LIPID CONTROL) (K040352)Bioresource Technology, Inc.2004-04-02
LINICAL ENZYME CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON SYSTEMS (K040535)Cliniqa Corporation2004-03-29
PRECINORM PROTEINS IN URINE/CSF PRECIPATH PROTEINS IN URINE/CSR CONTROLS (K040280)Roche Diagnostics Corp.2004-03-11
LIQUICHEK CARDIAC MARKER CONTROL LT (K040277)Bio-Rad Laboratories, Inc.2004-03-10
LYPHOCHEK ASSAYED CHEMISTRY CONTROL (K040273)Bio-Rad Laboratories, Inc.2004-03-04
LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS (K040091)Cliniqa Corporation2004-02-23
LIGAND PLUS CONTROL LEVEL 1-3 (K033344)Consolidated Technology2004-01-16
ELECSYS PRECICONTROL MULTIANALYTE (K033937)Roche Diagnostics Corp.2004-01-07
BAYER SPECIAL CHEMISTRY CONTROLS (K033379)Bayer Diagnostics Corp.2003-12-19
QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 (K033387)Bio-Rad2003-12-02
LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON ANALYZERS (K032074)Cliniqa Corporation2003-10-21
LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS (K033162)Cliniqa Corporation2003-10-10
AUDIT MICROCONTROLS MICROFD BNP CONTROL (K032122)Aalto Scientific, Ltd.2003-09-09
N/T PROTEIN CONTROL (K032237)Dade Behring, Inc.2003-09-05
ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL (K032453)Bionostics, Inc.2003-08-28
LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A - E FOR BECKMAN COULTER SYNCHRON SYSTEMS (K031921)Cliniqa Corporation2003-08-25
MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL (K032335)Medical Analysis Systems, Inc.2003-08-19
LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY PROTEIN SYSTEMS (K031577)Cliniqa Corporation2003-08-06
ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC (K032089)Roche Diagnostics Corp.2003-07-30
LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU ANALYZERS (K031575)Cliniqa Corporation2003-07-23
BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL (K031644)Bayer Healthcare, LLC2003-06-25
RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2 (K031101)Hemagen Diagnostics, Inc.2003-06-16
MAS CARDIOLMMUNE PROBNP LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL 1, 2 AND 3 (K031364)Medical Analysis Systems, Inc.2003-05-30
MAS CHEMTRAK H & DADE MONI-TROL H LIQUID ASSAYED CHEMISTRY CONTROL (K030942)Medical Analysis Systems, Inc.2003-04-28
BAYER ADVIA 1650 SPECIAL CHEMISTRY CONTROL (K030801)Bayer Healthcare, LLC2003-04-09
CLINIQA LIQUID QC TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3, AND TRI LEVEL (K030705)Cliniqa Corporation2003-03-26
WIENER LAB. STANDATROL S-E 2 NIVELES, LOVELS 1&2: 3X5 ML VIALS CAT.NR.1937553 (K030482)Wiener Laboratories2003-03-19
MAS LIPID LEVEL 1 AND 2 (K030679)Medical Analysis Systems, Inc.2003-03-14
LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A-E FOR THE OLYMPUS AU SERIES CHEMISTRY IMMUNO ANALYZERS (K030566)Cliniqa Corporation2003-03-13
BAYER LIGAND PLUS 1, 2, 3 CONTROLS (K030452)Bayer Diagnostics Corp.2003-03-03
LINICAL PROTEIN 5 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY AND IMMAGE PROTEIN SYSTEMS (K030150)Cliniqa Corporation2003-01-28
TRIAGE CARDIAC CONTROLS; TRIAGE CARDIO PROFILER CONTROLS (K030089)Biosite Incorporated2003-01-23
TRIAGE CARDIAC CALIBRATION VERIFICATION CONTROLS, TRIAGE CARDIO PROFILER CALIBRATION VERFICICATION CONTROLS (K030088)Biosite Incorporated2003-01-17
VALIDATE CHEM 10 CALIBRATION VERIFICATION TEST SET, MODEL 110 (K023410)Maine Standards Co.2003-01-06
QUICKCHECK LIQUID CHEMISTRY CONTROL (ASSAYED AND UNASSAYED), LEVELS 1, 2, AND 3 (K023731)Consolidated Technology2002-12-24
MAS CARDIOIMMUNE TL LOW LEVEL LIQUID ASSAYED CARDIAC MARKER CONTROL, DADE CARDIAC TL LOW LEVEL LIQUID ASSAYED CARDIAC MA (K023669)Medical Analysis Systems, Inc.2002-12-19
MAS T-MARKER, LEVEL 1,2 AND 3, DADE SPECIAL-T MARKER, LEVEL 1,2 AND 3 (K023867)Medical Analysis Systems, Inc.2002-12-17
LINICAL RF-CRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS (K023661)Cliniqa Corporation2002-12-06
VALIDATE CHEM 9 CALIBRATION VERIFICATION TEST SET, MODEL 109 (K023352)Maine Standards Co.2002-11-22
LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR THE BECKMAN-COULTER IMMAGE (K023250)Cliniqa Corporation2002-10-17
LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A - E FOR THE BECKMAN-COULTER IMMAGE (K022867)Cliniqa Corporation2002-10-02
LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER IMMAGE (K022936)Cliniqa Corporation2002-10-02
LINICAL PROTEIN 4 CALIBRATION VERIFIERS LEVELS-A-E FOR BECKMAN COULTER IMMAGE (K022885)Cliniqa Corporation2002-10-02
PH AND AMINES EXTERNAL CONTROL SET (K022851)Quidel Corp.2002-09-27
LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, AND 3-1 ML, MODEL 591, 592, 593; LEVEL 1, 2, AND 3-3 ML, MODEL 594, 595, 596 (K022991)Bio-Rad2002-09-17
RANDOX LIPID CONTROL (K022591)Randox Laboratories, Ltd.2002-08-30
PTS PANELS MULTI-CHEMISTRY CONTROLS (K022401)Polymer Technology Systems, Inc.2002-08-21
LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563 (K022041)Bio-Rad Laboratories, Inc.2002-07-16
MEDICA EASYQC BLOOD GAS/ELECTROLYTE CONTROL (K021930)Bionostics, Inc.2002-06-25
MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2 (K021381)Dade Behring, Inc.2002-06-10
LIQUICHEK URINE CHEMISTRY CONTROL (K020817)Bio-Rad Laboratories, Inc.2002-04-12
VALIDATE CHEM 8 CALIBRATION VERIFICATION TEST SET; MODEL 108 (K020450)Maine Standards Co.2002-03-21
IMMUNOASSAY PLUS CONTROL, LEVELS 1, 2, AND 3 (K020237)Consolidated Technology2002-03-19
MODIFICATION TO VIGIL LIPID CONTROL (K020521)Beckman Coulter, Inc.2002-03-01
MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL (K013995)Medical Analysis Systems, Inc.2001-12-21
MAS LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL 1 AND 2, DADE LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL (K013734)Medical Analysis Systems, Inc.2001-12-07
VALIDATE CHEM 7 CALIBRATION VERIFICATION TEST SET, MODEL 10007 (K013265)Maine Standards Co.2001-11-20
LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A=E FOR BECKMAN COULTER IMMAGE (K013332)Cliniqa Corporation2001-11-20
MODIFICATION TO SYNCHRON CONTROL (K013235)Beckman Coulter, Inc.2001-10-16
MODIFICATION TO N/T PROTEIN CONTROL SL (K012468)Dade Behring, Inc.2001-09-04
LIQUISPX LIQUID LIPID CONTROL (K012855)Clinical Controls Division2001-08-30
LIQUICHEK LIPIDS CONTROL LEVEL 1, LIQUICHEK LIPIDS CONTROL LEVEL 2, MODELS 641 AND 642 (K012513)Bio-Rad2001-08-29
COMBITROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, AUTOTROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3 (K012431)Bionostics, Inc.2001-08-28
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