LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A-E FOR THE OLYMPUS AU SERIES CHEMISTRY IMMUNO ANALYZERS


Device Classification Name

multi-analyte controls, all kinds (assayed)

510(k) Number K030566
Device Name LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A-E FOR THE OLYMPUS AU SERIES CHEMISTRY IMMUNO ANALYZERS
Applicant
CLINIQA CORPORATION
1432 south mission rd.
fallbrook, 
CA 
92028

Applicant Contact carol ruggiero
Correspondent
CLINIQA CORPORATION
1432 south mission rd.
fallbrook, 
CA 
92028

Correspodent Contact carol ruggiero
Regulation Number 862.1660
Classification Product Code
JJY  
Date Received 02/24/2003
Decision Date 03/13/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No