K-number	K001154
Device name	I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER
Applicant	I-Stat Corp.
Product code	JGS
Device class	Class II
Decision date	Apr 18, 2000
Decision	Substantially Equivalent
Regulation	862.1665

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View the full FDA submission: accessdata.fda.gov

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I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER

Everything you need for a 510(k) submission. Nothing you don't.