K-number	K150300
Device name	Liquichek Cardiac Markers Plus Control LT
Applicant	Bio-Rad Laboratories
Product code	JJY
Device class	Class I
Decision date	Dec 11, 2015
Decision	Substantially Equivalent
Regulation	862.1660

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View the full FDA submission: accessdata.fda.gov

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Liquichek Cardiac Markers Plus Control LT

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