K-number	K020355
Device name	I-STAT PROTHROMBIN TIME TEST
Applicant	I-Stat Corporation
Product code	GJS
Device class	Class II
Decision date	May 14, 2002
Decision	Substantially Equivalent
Regulation	864.7750

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View the full FDA submission: accessdata.fda.gov

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I-STAT PROTHROMBIN TIME TEST

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