K-number	K170854
Device name	HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls
Applicant	Instrumentation Laboratory CO
Product code	LCO
Device class	Class II
Decision date	Sep 8, 2017
Decision	Substantially Equivalent
Regulation	864.7695

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View the full FDA submission: accessdata.fda.gov

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HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls

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