K-number	K162822
Device name	ADAMS A1c HA-8180V, CALIBRATOR 80
Applicant	Arkray Factory, Inc.
Product code	PDJ
Device class	Class II
Decision date	Jun 29, 2017
Decision	Substantially Equivalent
Regulation	862.1373

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View the full FDA submission: accessdata.fda.gov

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ADAMS A1c HA-8180V, CALIBRATOR 80

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