Name: Predicase
Price: 199 USD

K-number	K161646
Device name	Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set
Applicant	Diazyme Laboratories
Product code	CGN
Device class	Class II
Decision date	Nov 4, 2016
Decision	Substantially Equivalent
Regulation	862.1295

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Source

View the full FDA submission: accessdata.fda.gov

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Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set

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