LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR THE DADE BN II NEPHELOMETER


Device Classification Name

single (specified) analyte controls (assayed and unassayed)

510(k) Number K022758
Device Name LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR THE DADE BN II NEPHELOMETER
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 08/20/2002
Decision Date 09/17/2002
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