ADVIA CHEMISTRY FERRITIN (FRT) METHOD


Device Classification Name

ferritin, antigen, antiserum, control

510(k) Number K110736
Device Name ADVIA CHEMISTRY FERRITIN (FRT) METHOD
Applicant
Siemens Healthcare Diagnostics Inc.
511 benedict avenue
tarrytown, 
NY 
10509

Applicant Contact kira gordon
Correspondent
Siemens Healthcare Diagnostics Inc.
511 benedict avenue
tarrytown, 
NY 
10509

Correspodent Contact kira gordon
Regulation Number 866.5340
Classification Product Code
DBF  
Subsequent Product Code
JIX  
Date Received 03/16/2011
Decision Date 08/17/2011
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

Recalls CDRH Recalls