DIAZYME CYSTATIN C POC TEST KIT


Device Classification Name

test, cystatin c

510(k) Number K111664
Device Name DIAZYME CYSTATIN C POC TEST KIT
Applicant
DIAZYME LABORATORIES
12889 gregg court
poway, 
CA 
92064

Applicant Contact abhijit datta
Correspondent
DIAZYME LABORATORIES
12889 gregg court
poway, 
CA 
92064

Correspodent Contact abhijit datta
Regulation Number 862.1225
Classification Product Code
NDY  
Subsequent Product Code
JJX  
Date Received 06/14/2011
Decision Date 03/30/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No