ST AIA-PACK hsE2 Calibrator Set— 510(k) K160113

Substantially Equivalent

Tosoh Bioscience, Inc.

FDA 510(k) clearance K160113 for ST AIA-PACK hsE2 Calibrator Set, Substantially Equivalent on 2016-02-17. Applicant: Tosoh Bioscience, Inc..

Clearance details

Applicant: Tosoh Bioscience, Inc.
Product code: 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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