K-number	K901120
Device name	KOAGULAB 60-S COAGULATION SYSTEM
Applicant	Ortho Diagnostic Systems, Inc.
Product code	GKP
Device class	Class II
Decision date	May 22, 1990
Decision	Substantially Equivalent
Regulation	864.5400

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View the full FDA submission: accessdata.fda.gov

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KOAGULAB 60-S COAGULATION SYSTEM

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