K-number	K143691
Device name	LDLC3 LDL-Cholesterol Gen.3
Applicant	Roche Diagnostics Operations (Rdo)
Product code	LBR
Device class	Class I
Decision date	Jan 28, 2015
Decision	Substantially Equivalent
Regulation	862.1475

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Source

View the full FDA submission: accessdata.fda.gov

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LDLC3 LDL-Cholesterol Gen.3

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