K-number	K160445
Device name	HemosIL Silica Clotting Time
Applicant	Instrumentation Laboratory CO
Product code	GFO
Device class	Class II
Decision date	Mar 16, 2016
Decision	Substantially Equivalent
Regulation	864.7925

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Source

View the full FDA submission: accessdata.fda.gov

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HemosIL Silica Clotting Time

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