DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ133A-CON)


Device Classification Name

test, cystatin c

510(k) Number K072270
Device Name DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ133A-CON)
Applicant
DIAZYME LABORATORIES
12889 gregg court
poway, 
CA 
92064

Applicant Contact charles yu
Correspondent
DIAZYME LABORATORIES
12889 gregg court
poway, 
CA 
92064

Correspodent Contact charles yu
Regulation Number 862.1225
Classification Product Code
NDY  
Subsequent Product Codes
JIT   JJX  
Date Received 08/15/2007
Decision Date 02/01/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No