LINICAL PROTEIN 5 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY AND IMMAGE PROTEIN SYSTEMS


Device Classification Name

multi-analyte controls, all kinds (assayed)

510(k) Number K030150
Device Name LINICAL PROTEIN 5 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY AND IMMAGE PROTEIN SYSTEMS
Original Applicant
CLINIQA CORPORATION
1432-b south mission rd.
fallbrook, 
CA 
92028

Original Contact carol ruggiero
Regulation Number 862.1660
Classification Product Code
JJY  
Date Received 01/15/2003
Decision Date 01/28/2003
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