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510(k) K161721

Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set by Diazyme Laboratories — Product Code CDD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2016
Date Received
June 22, 2016
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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