LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS


Device Classification Name

single (specified) analyte controls (assayed and unassayed)

510(k) Number K022491
Device Name LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS
Original Applicant
CLINIQA CORPORATION
1432 south mission rd.
fallbrook, 
CA 
92028

Original Contact carol ruggiero
Regulation Number 862.1660
Classification Product Code
JJX  
Date Received 07/29/2002
Decision Date 08/27/2002
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