Home / 510(k) Clearances / K160762

510(k) K160762

Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set by Diazyme Laboratories — Product Code LCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2016
Date Received
March 21, 2016
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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