Cliniqa Corporation

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
36
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K120900I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2May 31, 2013
K121237BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIMay 18, 2012
K083554CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3April 21, 2009
K081908CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2January 16, 2009
K082107CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2September 17, 2008
K080973CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AJune 2, 2008
K070741CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & 3May 4, 2007
K062916CLINIQA LIQUID QC CARDIAC MARKER CONTROL SP, LEVELS 1,2, &3October 23, 2006
K061182CLINIQA LIQUID QC LIPID CONTROL LEVELS 1 & 2;LINICAL LIPID CALIBRATION VERIFIERS LEVELS A-E FOR OLYMMay 25, 2006
K060322CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1March 21, 2006
K052679CLINIQA LIQUID QC BILIRUBIN CONTROLS LEVELS 1, 2 & 3; CLINIQA LINICAL BILIRUBIN CALIBRATION VERIFIERNovember 18, 2005
K041898CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FAugust 16, 2004
K040927LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERSMay 17, 2004
K040535LINICAL ENZYME CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON SYSTEMSMarch 29, 2004
K040455LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMSMarch 5, 2004
K040091LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMSFebruary 23, 2004
K033910OLYMPUS URINE CALIBRATORJanuary 30, 2004
K032074LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON ANALYZERSOctober 21, 2003
K033162LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMSOctober 10, 2003
K031921LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A - E FOR BECKMAN COULTER SYNCHRON SYSTEMSAugust 25, 2003