K-number	K953981
Device name	SYNTHASIL APTT REAGENT
Applicant	Ortho Diagnostic Systems, Inc.
Product code	GFO
Device class	Class II
Decision date	Nov 30, 1995
Decision	Substantially Equivalent
Regulation	864.7925

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View the full FDA submission: accessdata.fda.gov

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SYNTHASIL APTT REAGENT

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