K-number	K172903
Device name	HemosIL D-Dimer HS 500
Applicant	Instrumentation Laboratory CO
Product code	DAP
Device class	Class II
Decision date	Nov 22, 2017
Decision	Substantially Equivalent
Regulation	864.7320

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Source

View the full FDA submission: accessdata.fda.gov

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HemosIL D-Dimer HS 500

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