K-number	K900718
Device name	ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) ASSAY
Applicant	Roche Diagnostic Systems, Inc.
Product code	LCP
Device class	Class II
Decision date	Jun 12, 1990
Decision	Substantially Equivalent
Regulation	864.7470

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View the full FDA submission: accessdata.fda.gov

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ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) ASSAY

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