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510(k) K151786

Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet by Roche Diagnostics — Product Code CDD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 2015
Date Received
July 1, 2015
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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