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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
Device Name DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR
Applicant
Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr.
Newark,  DE  19714
Applicant Contact A. KATHLEEN B ENNIS
Correspondent
Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr.
Newark,  DE  19714
Correspondent 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 (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
Predetermined Change
Control Plan Authorized		 No
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