Name: Predicase
Price: 199 USD

K-number	K080973
Device name	CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC
Applicant	Cliniqa Corporation
Product code	JJY
Device class	Class I
Decision date	Jun 2, 2008
Decision	Substantially Equivalent
Regulation	862.1660

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View the full FDA submission: accessdata.fda.gov

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CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC

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