K162822

Substantially Equivalent

ADAMS A1c HA-8180V, CALIBRATOR 80

Applicant: Arkray Factory, Inc.
Product code: PDJ
Advisory panel: Clinical Chemistry
Date received: 2016-10-07
Decision date: 2017-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Koka-Shi, JP

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