Name: Predicase
Price: 199 USD

K-number	K955087
Device name	HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS
Applicant	Bayer Corp.
Product code	LCP
Device class	Class II
Decision date	Jun 13, 1996
Decision	Substantially Equivalent
Regulation	864.7470

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Source

View the full FDA submission: accessdata.fda.gov

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HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS

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