ADVIA CENTAUR VITAMIN D TOTAL ASSAY


Device Classification Name

system, test, vitamin d

510(k) Number K110586
Device Name ADVIA CENTAUR VITAMIN D TOTAL ASSAY
Applicant
Siemens Healthcare Diagnostics Inc.
511 benedict avenue
tarrytown, 
NY 
10509

Applicant Contact neil parker
Correspondent
Siemens Healthcare Diagnostics Inc.
511 benedict avenue
tarrytown, 
NY 
10509

Correspodent Contact neil parker
Regulation Number 862.1825
Classification Product Code
MRG  
Subsequent Product Codes
JIS   JJX  
Date Received 03/01/2011
Decision Date 10/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls