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510(k) K161646

Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set by Diazyme Laboratories — Product Code CGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2016
Date Received
June 15, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Folic, Radioimmunoassay
Device Class
Class II
Regulation Number
862.1295
Review Panel
CH
Submission Type

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