Name: Predicase
Price: 199 USD

K-number	K122722
Device name	COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160
Applicant	Roche Diagnostics
Product code	DFC
Device class	Class II
Decision date	Nov 29, 2012
Decision	Substantially Equivalent
Regulation	866.5600

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Source

View the full FDA submission: accessdata.fda.gov

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COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160

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