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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name radioassay, vitamin b12
510(k) Number K121994
Model K6442A, KC 640A
Device Name DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR
Original Applicant
SIEMENS HEALTHCARE DIAGNOSTICS INC.
500 gbc drive
newark,  DE  19714
Original Contact a. kathleen b ennis
Regulation Number862.1810
Classification Product Code
CDD  
Subsequent Product Code
JIX  
Date Received07/06/2012
Decision Date 11/30/2012
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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