K-number	K103788
Device name	PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT
Applicant	HORIBA ABX SAS
Product code	CFR
Device class	Class II
Decision date	Nov 8, 2011
Decision	Substantially Equivalent
Regulation	862.1345

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View the full FDA submission: accessdata.fda.gov

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PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT

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