DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET


Device Classification Name

c-reactive protein, antigen, antiserum, and control

510(k) Number K103557
Device Name DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET
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 Codes
JIT   JJX  
Date Received 12/02/2010
Decision Date 04/27/2011
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