K-number	K896830
Device name	OPTIMATE HEMOGLOBIN A1C
Applicant	Heraeus Kulzer, Inc.
Product code	LCP
Device class	Class II
Decision date	Sep 11, 1990
Decision	Substantially Equivalent
Regulation	864.7470

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View the full FDA submission: accessdata.fda.gov

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OPTIMATE HEMOGLOBIN A1C

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