DIAZYME HSCRP POC TEST KIT


Device Classification Name

c-reactive protein, antigen, antiserum, and control

510(k) Number K121558
Device Name DIAZYME HSCRP 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 866.5270
Classification Product Code
DCK  
Subsequent Product Code
JJX  
Date Received 05/29/2012
Decision Date 09/21/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No