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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 K133512
Device Name LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL)
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
500 GBC DRIVE
MS 514
NEWARK,  DE  19702
Applicant Contact ANNA MARIE K ENNIS
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS
500 GBC DRIVE
MS 514
NEWARK,  DE  19702
Correspondent Contact ANNA MARIE K ENNIS
Regulation Number862.1810
Classification Product Code
CDD  
Subsequent Product Code
JIX  
Date Received11/15/2013
Decision Date 01/02/2014
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
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