K-number	K120900
Device name	I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2
Applicant	Cliniqa Corporation
Product code	GGN
Device class	Class II
Decision date	May 31, 2013
Decision	Substantially Equivalent
Regulation	864.5425

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View the full FDA submission: accessdata.fda.gov

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I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2

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