LINICAL IMMUNOLOGY CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS


Device Classification Name

calibrator, multi-analyte mixture

510(k) Number K030074
Device Name LINICAL IMMUNOLOGY CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS
Original Applicant
CLINIQA CORPORATION
1432 south mission rd.
fallbrook, 
CA 
92028

Original Contact carol ruggiero
Regulation Number 862.1150
Classification Product Code
JIX  
Date Received 01/08/2003
Decision Date 01/21/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Immunology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No