Name: Predicase
Price: 199 USD

K-number	K072686
Device name	AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS
Applicant	Axis-Shield Diagnostics, Ltd.
Product code	LCP
Device class	Class II
Decision date	Mar 17, 2008
Decision	Substantially Equivalent
Regulation	864.7470

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Source

View the full FDA submission: accessdata.fda.gov

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AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS

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