Name: Predicase
Price: 199 USD

K-number	K143470
Device name	Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set
Applicant	Diazyme Laboratories
Product code	GIS
Device class	Class II
Decision date	Jan 31, 2016
Decision	Substantially Equivalent
Regulation	864.7340

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Source

View the full FDA submission: accessdata.fda.gov

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Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set

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