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Cliniqa Corporation

FDA 510(k) & PMA Approved Devices — 36 products

Total Devices36
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K120900 I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2GGN2013-05-31 View
510(k) K121237 BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LEJJX2012-05-18 View
510(k) K083554 CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3JJY2009-04-21 View
510(k) K081908 CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2JJW2009-01-16 View
510(k) K082107 CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2JJY2008-09-17 View
510(k) K080973 CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIACJJY2008-06-02 View
510(k) K070741 CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & 3JJY2007-05-04 View
510(k) K062916 CLINIQA LIQUID QC CARDIAC MARKER CONTROL SP, LEVELS 1,2, &3JJY2006-10-23 View
510(k) K061182 CLINIQA LIQUID QC LIPID CONTROL LEVELS 1 & 2;LINICAL LIPID CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS;QALIBJJY2006-05-25 View
510(k) K060322 CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYEDJIT2006-03-21 View
510(k) K052679 CLINIQA LIQUID QC BILIRUBIN CONTROLS LEVELS 1, 2 & 3; CLINIQA LINICAL BILIRUBIN CALIBRATION VERIFIERS LEVELS A-EJJX2005-11-18 View
510(k) K041898 CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMJJX2004-08-16 View
510(k) K040927 LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERSJJX2004-05-17 View
510(k) K040535 LINICAL ENZYME CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON SYSTEMSJJY2004-03-29 View
510(k) K040455 LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMSJJX2004-03-05 View
510(k) K040091 LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMSJJY2004-02-23 View
510(k) K033910 OLYMPUS URINE CALIBRATORJIX2004-01-30 View
510(k) K032074 LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON ANALYZERSJJY2003-10-21 View
510(k) K033162 LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMSJJY2003-10-10 View
510(k) K031921 LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A - E FOR BECKMAN COULTER SYNCHRON SYSTEMSJJY2003-08-25 View
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