K-number	K003120
Device name	MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C
Applicant	Roche Diagnostics Corp.
Product code	LCP
Device class	Class II
Decision date	Dec 18, 2000
Decision	Substantially Equivalent
Regulation	864.7470

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MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C

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