K-number	K112015
Device name	PREMIER HB9210 HBA1C ANALYZER
Applicant	Primus Corporation Dba Trinity Biotech
Product code	LCP
Device class	Class II
Decision date	Nov 22, 2011
Decision	Substantially Equivalent
Regulation	864.7470

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View the full FDA submission: accessdata.fda.gov

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PREMIER HB9210 HBA1C ANALYZER

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