ADAMS A1c HA-8180V, CALIBRATOR 80— 510(k) K162822

Substantially Equivalent

Arkray Factory, Inc.

FDA 510(k) clearance K162822 for ADAMS A1c HA-8180V, CALIBRATOR 80, Substantially Equivalent on 2017-06-29. Applicant: Arkray Factory, Inc..

Clearance details

Applicant: Arkray Factory, Inc.
Product code: 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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