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510(k) K133512

LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL) by Siemens Healthcare Diagnostics — Product Code CDD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 2, 2014
Date Received
November 15, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioassay, Vitamin B12
Device Class
Class II
Regulation Number
862.1810
Review Panel
CH
Submission Type

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