Name: Predicase
Price: 199 USD

K-number	K031873
Device name	I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VERIFICATION CONTROL SET
Applicant	I-Stat Corporation
Product code	JJX
Device class	Class I
Decision date	Oct 7, 2003
Decision	Substantially Equivalent
Regulation	862.1660

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View the full FDA submission: accessdata.fda.gov

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I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VERIFICATION CONTROL SET

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