K-number	K994349
Device name	COAGUCHEK S SYSTEM, MODEL 2138280
Applicant	Roche Diagnostics Corp.
Product code	JPA
Device class	Class II
Decision date	Sep 6, 2000
Decision	Substantially Equivalent
Regulation	864.5425

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View the full FDA submission: accessdata.fda.gov

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COAGUCHEK S SYSTEM, MODEL 2138280

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