Name: Predicase
Price: 199 USD

K-number	K170864
Device name	VALIDATE D-Dimer Calibration Verification / Linearity Test Kit
Applicant	Maine Standards Company, LLC
Product code	GGN
Device class	Class II
Decision date	Jun 21, 2017
Decision	Substantially Equivalent
Regulation	864.5425

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Source

View the full FDA submission: accessdata.fda.gov

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VALIDATE D-Dimer Calibration Verification / Linearity Test Kit

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