K-number	K862554
Device name	IMMPULSE PHENYTOIN ASSAY REAGENT
Applicant	Sclavo, Inc.
Product code	LGR
Device class	Class II
Decision date	Jul 16, 1986
Decision	Substantially Equivalent
Regulation	862.3350

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View the full FDA submission: accessdata.fda.gov

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IMMPULSE PHENYTOIN ASSAY REAGENT

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