ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS


Device Classification Name

cardiac c-reactive protein, antigen, antiserum, and control

510(k) Number K081294
Device Name ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS
Applicant
Siemens Healthcare Diagnostics Inc.
511 benedict ave.
tarrytown, 
NY 
10591

Applicant Contact philip liu
Correspondent
Siemens Healthcare Diagnostics Inc.
511 benedict ave.
tarrytown, 
NY 
10591

Correspodent Contact philip liu
Regulation Number 866.5270
Classification Product Code
NQD  
Subsequent Product Code
JIX  
Date Received 05/07/2008
Decision Date 07/29/2008
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