ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS


Device Classification Name

system, test, c-reactive protein

510(k) Number K072658
Device Name ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS
Applicant
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
511 benedict avenue
tarrytown, 
NY 
10591

Applicant Contact philip liu
Correspondent
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
511 benedict avenue
tarrytown, 
NY 
10591

Correspodent Contact philip liu
Regulation Number 866.5270
Classification Product Code
DCN  
Subsequent Product Code
JIX  
Date Received 09/20/2007
Decision Date 04/01/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No