Cliniqa Corporation
San Marcos, CA, US
CLINIQA CORPORATION appears in FDA device records in San Marcos, CA. FDA records list 36 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 36 510(k) clearances for Cliniqa Corporation between 2001 and 2013. The busiest year on record is 2003, with 10. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2002 | 8 |
| 2003 | 10 |
| 2004 | 6 |
| 2005 | 1 |
| 2006 | 3 |
| 2007 | 1 |
| 2008 | 2 |
| 2009 | 2 |
| 2012 | 1 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K120900 | I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2 | GGN | Substantially Equivalent | |
| K121237 | BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE | JJX | Substantially Equivalent | |
| K083554 | CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3 | JJY | Substantially Equivalent | |
| K081908 | CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2 | JJW | Substantially Equivalent | |
| K082107 | CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2 | JJY | Substantially Equivalent | |
| K080973 | CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC | JJY | Substantially Equivalent | |
| K070741 | CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & 3 | JJY | Substantially Equivalent | |
| K062916 | CLINIQA LIQUID QC CARDIAC MARKER CONTROL SP, LEVELS 1,2, &3 | JJY | Substantially Equivalent | |
| K061182 | CLINIQA LIQUID QC LIPID CONTROL LEVELS 1 & 2;LINICAL LIPID CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS;QALIB | JJY | Substantially Equivalent | |
| K060322 | CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED | JIT | Substantially Equivalent | |
| K052679 | CLINIQA LIQUID QC BILIRUBIN CONTROLS LEVELS 1, 2 & 3; CLINIQA LINICAL BILIRUBIN CALIBRATION VERIFIERS LEVELS A-E | JJX | Substantially Equivalent | |
| K041898 | CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEM | JJX | Substantially Equivalent | |
| K040927 | LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS | JJX | Substantially Equivalent | |
| K040535 | LINICAL ENZYME CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON SYSTEMS | JJY | Substantially Equivalent | |
| K040455 | LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMS | JJX | Substantially Equivalent | |
| K040091 | LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS | JJY | Substantially Equivalent | |
| K033910 | OLYMPUS URINE CALIBRATOR | JIX | Substantially Equivalent | |
| K032074 | LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON ANALYZERS | JJY | Substantially Equivalent | |
| K033162 | LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS | JJY | Substantially Equivalent | |
| K031921 | LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A - E FOR BECKMAN COULTER SYNCHRON SYSTEMS | JJY | Substantially Equivalent | |
| K031577 | LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY PROTEIN SYSTEMS | JJY | Substantially Equivalent | |
| K031575 | LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU ANALYZERS | JJY | Substantially Equivalent | |
| K030705 | CLINIQA LIQUID QC TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3, AND TRI LEVEL | JJY | Substantially Equivalent | |
| K030768 | CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL | JJT | Substantially Equivalent | |
| K030566 | LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A-E FOR THE OLYMPUS AU SERIES CHEMISTRY IMMUNO ANALYZERS | JJY | Substantially Equivalent | |
| K030150 | LINICAL PROTEIN 5 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY AND IMMAGE PROTEIN SYSTEMS | JJY | Substantially Equivalent | |
| K030074 | LINICAL IMMUNOLOGY CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS | JIX | Substantially Equivalent | |
| K023661 | LINICAL RF-CRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS | JJY | Substantially Equivalent | |
| K023250 | LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR THE BECKMAN-COULTER IMMAGE | JJY | Substantially Equivalent | |
| K022936 | LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER IMMAGE | JJY | Substantially Equivalent | |
| K022885 | LINICAL PROTEIN 4 CALIBRATION VERIFIERS LEVELS-A-E FOR BECKMAN COULTER IMMAGE | JJY | Substantially Equivalent | |
| K022867 | LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A - E FOR THE BECKMAN-COULTER IMMAGE | JJY | Substantially Equivalent | |
| K022758 | LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR THE DADE BN II NEPHELOMETER | JJX | Substantially Equivalent | |
| K022491 | LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS | JJX | Substantially Equivalent | |
| K022232 | CLINIQA LIQUID-QC HCG CONTROL LEVEL 1, 2, AND 3 | JJX | Substantially Equivalent | |
| K013332 | LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A=E FOR BECKMAN COULTER IMMAGE | JJY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2085064 | 1000135102 | CLINIQA CORPORATION | 495 Enterprise Street, San Marcos, CA 92078 US | 2026 | and 44 more, listed in full below |
| 3010725882 | 3010725882 | CLINIQA CORPORATION | 258 la Moree Rd, San Marcos, CA 92078 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KNKAcid, Uric, Uricase (Colorimetric)
- DCFAlbumin, Antigen, Antiserum, Control
- DKCAlcohol Control Materials
- CGXAlkaline Picrate, Colorimetry, Creatinine
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- GTQAntistreptolysin - Titer/Streptolysin O Reagent
- MSJApolipoproteins
- LCPAssay, Glycosylated Hemoglobin
- CJYAzo Dye, Calcium
- QATBrain Trauma Assessment Test
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- JIXCalibrator, Multi-Analyte Mixture
- JISCalibrator, Primary
- JITCalibrator, Secondary
- JFJCatalytic Methods, Amylase
- JPZColorimetric Method, Gamma-Glutamyl Transpeptidase
- DIHColorimetry, Cholinesterase
- CICCresolphthalein Complexone, Calcium
- CIGDiazo Colorimetry, Bilirubin
- GIFDiluent, Blood Cell
- CEMElectrode, Ion Specific, Potassium
- JGSElectrode, Ion Specific, Sodium
- CGZElectrode, Ion-Specific, Chloride
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- JIFEnzymatic Method, Ammonia
- JFYEnzymatic Method, Creatinine
- KHSEnzymatic, Carbon-Dioxide
- JJTEnzyme Controls (Assayed And Unassayed)
- PPMGeneral Purpose Reagent
- DADHaptoglobin, Antigen, Antiserum, Control
- CFRHexokinase, Glucose
- JQBKinetic Method, Gamma-Glutamyl Transpeptidase
- LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
- LBRLdl & Vldl Precipitation, Hdl
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- DFCLipoprotein, Low-Density, Antigen, Antiserum, Control
- CHJMercuric Thiocyanate, Colorimetry, Chloride
- OHQMulti-Analyte Controls Unassayed
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- JIYPhotometric Method, Iron (Non-Heme)
- JGJPhotometric Method, Magnesium
- GGNPlasma, Coagulation Control
- JZJPrealbumin, Antigen, Antiserum, Control
- GGKProducts, Red-Cell Lysing Products
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- DCNSystem, Test, C-Reactive Protein
- MRRSystem, Test, Low Density, Lipoprotein
- GJSTest, Time, Prothrombin
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
- CDNUrease, Photometric, Urea Nitrogen
- JJWUrinalysis Controls (Assayed And Unassayed)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain