K-number	K103195
Device name	I-STAT 1 WIRELESS ANALYZER
Applicant	Abbott Point of Care, Inc.
Product code	CGA
Device class	Class II
Decision date	Feb 8, 2011
Decision	Substantially Equivalent
Regulation	862.1345

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Source

View the full FDA submission: accessdata.fda.gov

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I-STAT 1 WIRELESS ANALYZER

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