K-number	K030845
Device name	COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING
Applicant	Roche Diagnostics Corp.
Product code	GJS
Device class	Class II
Decision date	May 22, 2003
Decision	Substantially Equivalent
Regulation	864.7750

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View the full FDA submission: accessdata.fda.gov

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COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING

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