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510(k) K133803

DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT by Diazyme Laboratories — Product Code LCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2014
Date Received
December 16, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Glycosylated Hemoglobin
Device Class
Class II
Regulation Number
864.7470
Review Panel
HE
Submission Type

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