K-number	K023582
Device name	I-STAT KAOLIN ACT TEST
Applicant	I-Stat Corporation
Product code	JBP
Device class	Class II
Decision date	Sep 8, 2003
Decision	Substantially Equivalent
Regulation	864.7140

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View the full FDA submission: accessdata.fda.gov

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I-STAT KAOLIN ACT TEST

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