Name: Predicase
Price: 199 USD

K-number	K080811
Device name	TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN C CONTROL SET
Applicant	Roche Diagnostics Corp.
Product code	NDY
Device class	Class II
Decision date	Jun 20, 2008
Decision	Substantially Equivalent
Regulation	862.1225

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Source

View the full FDA submission: accessdata.fda.gov

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TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN C CONTROL SET

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