Name: Predicase
Price: 199 USD

K-number	K122472
Device name	VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM
Applicant	Bio-Rad Laboratories, Inc., Clinical Systems Divis
Product code	LCP
Device class	Class II
Decision date	Oct 26, 2012
Decision	Substantially Equivalent
Regulation	864.7470

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Source

View the full FDA submission: accessdata.fda.gov

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VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM

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