Name: Predicase
Price: 199 USD

K-number	K141143
Device name	COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET
Applicant	Roche Diagnostics
Product code	NDY
Device class	Class II
Decision date	Jul 17, 2014
Decision	Substantially Equivalent
Regulation	862.1225

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Source

View the full FDA submission: accessdata.fda.gov

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COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET

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