DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR


Device Classification Name

radioassay, vitamin b12

510(k) Number K121994
Device Name DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR
Applicant
Siemens Healthcare Diagnostics Inc.
500 gbc drive
newark, 
DE 
19714

Applicant Contact a. kathleen b ennis
Correspondent
Siemens Healthcare Diagnostics Inc.
500 gbc drive
newark, 
DE 
19714

Correspodent Contact a. kathleen b ennis
Regulation Number 862.1810
Classification Product Code
CDD  
Subsequent Product Code
JIX  
Date Received 07/06/2012
Decision Date 11/30/2012
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