K160113

Substantially Equivalent

ST AIA-PACK hsE2 Calibrator Set

Applicant: Tosoh Bioscience, Inc.
Product code: JIT
Advisory panel: Clinical Chemistry
Date received: 2016-01-19
Decision date: 2016-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South San Franciso, CA, US

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