Medical Device Manufacturer · US , Fallbrook , CA

Cliniqa Corporation

36 submissions · 36 cleared · Since 2001
36
Total
36
Cleared
0
Denied

Cliniqa Corporation — FDA 510(k) Submissions

Cliniqa Corporation has submitted 36 FDA 510(k) premarket notifications since 2001, of which 36 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Multi-analyte Controls, All Kinds (assayed), Single (specified) Analyte Controls (assayed And Unassayed), Calibrator, Multi-analyte Mixture, Enzyme Controls (assayed And Unassayed), Calibrator, Secondary . Use the specialty filter in the sidebar to narrow results.

36 devices
1–25 of 36
I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2
K120900 · GGN Plasma, Coagulation Control · Hematology
May 2013 431d
BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE
K121237 · JJX Single (specified)... · Chemistry
May 2012 24d
CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3
K083554 · JJY Multi-analyte Controls,... · Chemistry
Apr 2009 141d
CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2
K081908 · JJW Urinalysis Controls... · Chemistry
Jan 2009 197d
CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2
K082107 · JJY Multi-analyte Controls,... · Chemistry
Sep 2008 54d
CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC
K080973 · JJY Multi-analyte Controls,... · Chemistry
Jun 2008 59d
CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & 3
K070741 · JJY Multi-analyte Controls,... · Chemistry
May 2007 49d
CLINIQA LIQUID QC CARDIAC MARKER CONTROL SP, LEVELS 1,2, &3
K062916 · JJY Multi-analyte Controls,... · Chemistry
Oct 2006 25d
CLINIQA LIQUID QC LIPID CONTROL LEVELS 1 & 2;LINICAL LIPID CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS;QALIB
K061182 · JJY Multi-analyte Controls,... · Chemistry
May 2006 28d
CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED
K060322 · JIT Calibrator, Secondary · Chemistry
Mar 2006 40d
CLINIQA LIQUID QC BILIRUBIN CONTROLS LEVELS 1, 2 & 3; CLINIQA LINICAL BILIRUBIN CALIBRATION VERIFIERS LEVELS A-E
K052679 · JJX Single (specified)... · Chemistry
Nov 2005 51d
CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEM
K041898 · JJX Single (specified)... · Chemistry
Aug 2004 33d
LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS
K040927 · JJX Single (specified)... · Chemistry
May 2004 38d
LINICAL ENZYME CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON SYSTEMS
K040535 · JJY Multi-analyte Controls,... · Chemistry
Mar 2004 27d
LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMS
K040455 · JJX Single (specified)... · Chemistry
Mar 2004 11d
LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS
K040091 · JJY Multi-analyte Controls,... · Chemistry
Feb 2004 38d
OLYMPUS URINE CALIBRATOR
K033910 · JIX Calibrator, Multi-analyte... · Chemistry
Jan 2004 44d
LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON ANALYZERS
K032074 · JJY Multi-analyte Controls,... · Chemistry
Oct 2003 106d
LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS
K033162 · JJY Multi-analyte Controls,... · Chemistry
Oct 2003 10d
LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A - E FOR BECKMAN COULTER SYNCHRON SYSTEMS
K031921 · JJY Multi-analyte Controls,... · Chemistry
Aug 2003 63d
LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY PROTEIN SYSTEMS
K031577 · JJY Multi-analyte Controls,... · Chemistry
Aug 2003 78d
LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU ANALYZERS
K031575 · JJY Multi-analyte Controls,... · Immunology
Jul 2003 64d
CLINIQA LIQUID QC TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3, AND TRI LEVEL
K030705 · JJY Multi-analyte Controls,... · Chemistry
Mar 2003 20d
CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL
K030768 · JJT Enzyme Controls (assayed... · Chemistry
Mar 2003 10d
LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A-E FOR THE OLYMPUS AU SERIES CHEMISTRY IMMUNO ANALYZERS
K030566 · JJY Multi-analyte Controls,... · Chemistry
Mar 2003 17d
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