Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2085064

FEI Number

1000135102

Entity Name

CLINIQA CORPORATION

City/State/Country

San Marcos, CA, US

Establishment Address

495 Enterprise Street, San Marcos, CA 92078, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CLINIQA CORPORATION (Owner Number: 2083131)

Owner / Operator Contact Address

495 Enterprise Street, --, San Marcos, CA 92078, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K955691

PMA Number

N/A

All Registered Proprietary Names

Lipid Calibrator LDL Cholesterol Direct LINICAL PROTEIN 4 CALIBRATIO CREATININE REAGENT CRP REAGENT Cardiac Marker PT PROTEIN 5 CALIBRATION VERIFIERS A-E Uric Acid Reagent Liquid QC® Cardiac Marker Control VS CARDIAC MARKER CONTROL SP 1,2 &3 GGT Reagent GOT (AST) REAGENT LDH-P Reagent APO A-1 Reagent LIQUID QC CARDIAC MARKER CONTROL Phosphorus Reagent Lipid Calibrator Assayed Control Serum Level 2 Assayed Control Serum Level 1 LIQUID QC TDM CONTROL Amylase Reagent LiquidQC NEPHROCHECK® Control For VIDAS® 3 NEPHROCHECK® Method Validation For VIDAS® 3 NEPHROCHECK® Calibration Verification For VIDAS® 3 BUN Liquid Reagent LIQUID QC URINALYSIS CONTROLS 1 &2 CALCIUM (OCPC) LIQUID REAGENT CHOLESTEROL RAPID LIQUID REAGENT Triglycerides GPO CALCIUM REAGENT ISTAT PTPLUS CONTROL LEVEL 1; ISTAT PTPLUS CONTROL LEVEL 2 ESOTERICS CALIBRATION VERIFIERS A-E TUMOR MARKER CONTROL 1,2 3 & TRI LIPID CONTROL1& 2;CALIB VERIF A-Z CHOLINESTERASE REAGENT Cholesterol Enzymatic Ethanol/Ammonia control levels 1-3 Alkaline Phosphatase Reagent FRUCTOSAMINE CONTROLS URIC ACID CALIB VERIFIERS A-E HbA1c Reagent and Calibrator CK-MB Reagent Iron TIBC Reagent Cliniqa LIquid QC Unassayed and Ass LiquidQC hsCRP Controls ENZYME CALIB VERIFIERS A-E Liquid QC Unassayed General Chemistry Control DRY QC CHEMISTRY CONTROL PROTEIN 2 CALIBRATION VERIFIERS A-E CK NADP Reagent I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2 I-STAT PTPLUS CONTROL LEVEL 1; ISTAT PTPLUS CONTROL LEVEL 2 AMYLASE REAGENT PROTEIN 2 CALIB VERIFIERS LEVEL A-E IMMUNOLOGY CALIBRATION VERIFIER A-E PROTEIN 1 CALIB VERIFIERS A-E LDL Cholesterol Direct HSCRP CALIB VERIFIERS LEVELS A-E CREATININE REAGENT (ENZYMATIC) ImmuTROL LiquidQC Immunology Control LINICAL PROTEIN 4 CALIBRATIO Cardiac marker complete DIABETES CONTROL Vitamin D Control CoV-2 IgG Control CoV-2 Ag Control BILIRUBIN CONTROLS1,2 &3;CALB A-Z OLYMPUS URINE CALIBRATOR Glucose UV Reagent HSCRP CALIB VERIFIERS LEVELS A-E BILIRUBIN STANDARD Roche ISE Standard PROTEIN 4 CALIB VERIFIERS LEVEL A-E CHLORIDE REAGENT HDL-Cholesterol Direct CO2 REAGENT APO B Reagent BILIRUBIN REAGENT TOTAL/DIRECT WHOLE BLD VOLATILES CONTROL LEVELS1 AND 2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LBS	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	Clinical Chemistry	Class 1	862.1475	2013-04-09
JZJ	Prealbumin, Antigen, Antiserum, Control	Immunology	Class 1	866.5060	2006-06-13
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2011-07-22
DCN	System, Test, C-Reactive Protein	Immunology	Class 2	866.5270	2011-07-22
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2013-12-17
QAT	Brain Trauma Assessment Test	Immunology	Class 2	866.5830	2024-05-29
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2019-01-09
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2009-11-09
KNK	Acid, Uric, Uricase (Colorimetric)	Clinical Chemistry	Class 1	862.1775	2011-07-22
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2009-11-09
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2023-08-09
JPZ	Colorimetric Method, Gamma-Glutamyl Transpeptidase	Clinical Chemistry	Class 1	862.1360	2013-01-04
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2011-07-21
CFJ	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	Clinical Chemistry	Class 2	862.1440	2011-07-22
MSJ	Apolipoproteins	Clinical Chemistry	Class 1	862.1475	2011-07-21
JJT	Enzyme Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2006-04-06
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Clinical Chemistry	Class 1	862.1580	2014-02-19
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2010-03-25
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2014-02-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2006-06-13
JFJ	Catalytic Methods, Amylase	Clinical Chemistry	Class 2	862.1070	2011-07-21
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2023-07-10
CDN	Urease, Photometric, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2013-01-04
JJW	Urinalysis Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2009-11-09
CIC	Cresolphthalein Complexone, Calcium	Clinical Chemistry	Class 2	862.1145	2011-07-22
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2011-07-22
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	Clinical Chemistry	Class 1	862.1705	2011-07-22
CJY	Azo Dye, Calcium	Clinical Chemistry	Class 2	862.1145	2011-07-22
GJS	Test, Time, Prothrombin	Hematology	Class 2	864.7750	2024-02-23
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2009-11-09
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2009-11-09
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2009-11-09
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2009-11-09
DIH	Colorimetry, Cholinesterase	Clinical Toxicology	Class 1	862.3240	2011-07-22
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2011-07-22
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2014-06-27
CJE	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	Clinical Chemistry	Class 2	862.1050	2011-07-21
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2011-07-22
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2009-11-09
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2010-06-30
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2024-09-09
JGJ	Photometric Method, Magnesium	Clinical Chemistry	Class 1	862.1495	2011-07-22
JIY	Photometric Method, Iron (Non-Heme)	Clinical Chemistry	Class 1	862.1410	2011-07-22
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2007-12-31
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	Class 1	862.1030	2013-01-04
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2010-06-17
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2009-11-09
OHQ	Multi-Analyte Controls Unassayed	Clinical Chemistry	Class 1	862.1660	2014-04-15
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2006-06-13
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2006-06-13
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2009-11-09
CGS	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2011-07-22
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2013-09-16
JFJ	Catalytic Methods, Amylase	Clinical Chemistry	Class 2	862.1070	2011-07-21
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2009-11-09
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2009-11-09
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2009-11-09
MRR	System, Test, Low Density, Lipoprotein	Clinical Chemistry	Class 1	862.1475	2011-07-22
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2009-11-09
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2011-07-22
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2010-05-25
JZJ	Prealbumin, Antigen, Antiserum, Control	Immunology	Class 1	866.5060	2006-06-13
DCF	Albumin, Antigen, Antiserum, Control	Immunology	Class 2	866.5040	2006-06-13
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2009-11-09
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2007-12-31
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2018-08-20
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2009-11-09
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2006-06-13
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2011-07-22
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2009-11-09
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2011-07-21
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2010-07-20
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2010-07-20
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2010-07-20
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2010-07-20
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2009-11-09
CHJ	Mercuric Thiocyanate, Colorimetry, Chloride	Clinical Chemistry	Class 2	862.1170	2011-07-22
LBR	Ldl & Vldl Precipitation, Hdl	Clinical Chemistry	Class 1	862.1475	2011-07-22
KHS	Enzymatic, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2011-07-22
DFC	Lipoprotein, Low-Density, Antigen, Antiserum, Control	Immunology	Class 2	866.5600	2011-07-21
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2011-07-22
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2018-08-20

Official Correspondent

Dawn Gast

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CLINIQA CORPORATION

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010725882	CLINIQA CORPORATION	San Marcos, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K242685	Siemens Healthcare Diagnostics, Inc.	Atellica® CH Creatinine_3 (Crea3)	2024-12-04
K161494	Siemens Healthcare Diagnostics, Inc.	Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)	2016-11-15
K083412	Mitsubishi Kagaku Iatron	PATHFAST HSCRP	2009-03-09
K882259	Diagnostic Chemicals, Ltd. (Usa)	DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023	1988-07-21
K060322	Cliniqa Corporation	CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED	2006-03-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2009	Roche Diagnostics Corp.	1	Roche Diagnostics HDLC3, HDL-Cholesterol Plus 3rd Generation, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 04399803190. An in-vitro diagnostic reagent system intended for use on COMAS Integra systems for the quantitative determination of HDL-cholesterol in serum and plasma.
Z-0012-2009	Roche Diagnostics Corp.	2	Roche Diagnostics NAPA2, N-Acetyl-Procainamide, COBAS INTEGRA, Roche Diagnostics, Indianapolis, IN.; 20737852322. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the qualitative determination of NAPA in serum or plasma.
Z-0024-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.
Z-0024-2015	Siemens Healthcare Diagnostics, Inc.	2	Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System.
Z-0025-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2085064. Last updated year: 2026. Please use registration number 2085064 when referencing this establishment in official correspondence.