Name: Predicase
Price: 199 USD

K-number	K010111
Device name	CARDIOIMMUNE TL CARDIAC MARKER CONTROL LEVELS 1, 2, 3, AND MULTI-PACK
Applicant	Medical Analysis Systems, Inc.
Product code	JJY
Device class	Class I
Decision date	Feb 28, 2001
Decision	Substantially Equivalent
Regulation	862.1660

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Source

View the full FDA submission: accessdata.fda.gov

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CARDIOIMMUNE TL CARDIAC MARKER CONTROL LEVELS 1, 2, 3, AND MULTI-PACK

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