Name: Predicase
Price: 199 USD

K-number	K160762
Device name	Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set
Applicant	Diazyme Laboratories
Product code	LCP
Device class	Class II
Decision date	Nov 21, 2016
Decision	Substantially Equivalent
Regulation	864.7470

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Source

View the full FDA submission: accessdata.fda.gov

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Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set

Everything you need for a 510(k) submission. Nothing you don't.