CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC


Device Classification Name

multi-analyte controls, all kinds (assayed)

510(k) Number K080973
Device Name CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC
Applicant
CLINIQA CORPORATION
774 n. twin oaks valley rd.
san marcos, 
CA 
92069

Applicant Contact carol ruggiero
Correspondent
CLINIQA CORPORATION
774 n. twin oaks valley rd.
san marcos, 
CA 
92069

Correspodent Contact carol ruggiero
Regulation Number 862.1660
Classification Product Code
JJY  
Date Received 04/04/2008
Decision Date 06/02/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No