K-number	K201311
Device name	PF4 IgG assay
Applicant	Immucor Gti Diagnostics, Inc.
Product code	LCO
Device class	Class II
Decision date	Jun 18, 2020
Decision	Substantially Equivalent
Regulation	864.7695

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Source

View the full FDA submission: accessdata.fda.gov

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PF4 IgG assay

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