K-number	K915418
Device name	ELLAGIC ACID APTT REAGENT
Applicant	Helena Laboratories
Product code	GFO
Device class	Class II
Decision date	Feb 14, 1992
Decision	Substantially Equivalent
Regulation	864.7925

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View the full FDA submission: accessdata.fda.gov

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ELLAGIC ACID APTT REAGENT

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