Name: Predicase
Price: 199 USD

K-number	K063643
Device name	MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM
Applicant	Bio-Rad Laboratories Inc., Clinical Systems Divisi
Product code	LCP
Device class	Class II
Decision date	Dec 27, 2006
Decision	Substantially Equivalent
Regulation	864.7470

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Source

View the full FDA submission: accessdata.fda.gov

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MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM

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