FDA 510(k) Applications Submitted by CLINIQA CORPORATION

FDA 510(k) Number Submission Date Device Name Applicant
K030074 01/08/2003 LINICAL IMMUNOLOGY CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS CLINIQA CORPORATION
K030150 01/15/2003 LINICAL PROTEIN 5 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY AND IMMAGE PROTEIN SYSTEMS CLINIQA CORPORATION
K040091 01/16/2004 LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS CLINIQA CORPORATION
K060322 02/09/2006 CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED CLINIQA CORPORATION
K040455 02/23/2004 LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMS CLINIQA CORPORATION
K030566 02/24/2003 LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A-E FOR THE OLYMPUS AU SERIES CHEMISTRY IMMUNO ANALYZERS CLINIQA CORPORATION
K040535 03/02/2004 LINICAL ENZYME CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON SYSTEMS CLINIQA CORPORATION
K030705 03/06/2003 CLINIQA LIQUID QC TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3, AND TRI LEVEL CLINIQA CORPORATION
K030768 03/11/2003 CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL CLINIQA CORPORATION
K070741 03/16/2007 CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & 3 CLINIQA CORPORATION
K080973 04/04/2008 CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC CLINIQA CORPORATION
K040927 04/09/2004 LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS CLINIQA CORPORATION
K061182 04/27/2006 CLINIQA LIQUID QC LIPID CONTROL LEVELS 1 & 2;LINICAL LIPID CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS;QALIB CLINIQA CORPORATION
K031575 05/20/2003 LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU ANALYZERS CLINIQA CORPORATION
K031577 05/20/2003 LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY PROTEIN SYSTEMS CLINIQA CORPORATION
K031921 06/23/2003 LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A - E FOR BECKMAN COULTER SYNCHRON SYSTEMS CLINIQA CORPORATION
K081908 07/03/2008 CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2 CLINIQA CORPORATION
K032074 07/07/2003 LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON ANALYZERS CLINIQA CORPORATION
K022232 07/10/2002 CLINIQA LIQUID-QC HCG CONTROL LEVEL 1, 2, AND 3 CLINIQA CORPORATION
K041898 07/14/2004 CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEM CLINIQA CORPORATION
K082107 07/25/2008 CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2 CLINIQA CORPORATION
K022491 07/29/2002 LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS CLINIQA CORPORATION
K022758 08/20/2002 LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR THE DADE BN II NEPHELOMETER CLINIQA CORPORATION
K022867 08/28/2002 LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A - E FOR THE BECKMAN-COULTER IMMAGE CLINIQA CORPORATION
K022885 08/30/2002 LINICAL PROTEIN 4 CALIBRATION VERIFIERS LEVELS-A-E FOR BECKMAN COULTER IMMAGE CLINIQA CORPORATION
K022936 09/04/2002 LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER IMMAGE CLINIQA CORPORATION
K052679 09/28/2005 CLINIQA LIQUID QC BILIRUBIN CONTROLS LEVELS 1, 2 & 3; CLINIQA LINICAL BILIRUBIN CALIBRATION VERIFIERS LEVELS A-E CLINIQA CORPORATION
K062916 09/28/2006 CLINIQA LIQUID QC CARDIAC MARKER CONTROL SP, LEVELS 1,2, &3 CLINIQA CORPORATION
K023250 09/30/2002 LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR THE BECKMAN-COULTER IMMAGE CLINIQA CORPORATION
K033162 09/30/2003 LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS CLINIQA CORPORATION
K013332 10/09/2001 LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A=E FOR BECKMAN COULTER IMMAGE CLINIQA CORPORATION
K023661 10/31/2002 LINICAL RF-CRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS CLINIQA CORPORATION
K033910 12/17/2003 OLYMPUS URINE CALIBRATOR CLINIQA CORPORATION
K120900 03/26/2012 I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2 CLINIQA CORPORATION
K121237 04/24/2012 BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE CLINIQA CORPORATION
K083554 12/01/2008 CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3 CLINIQA CORPORATION


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