ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set— 510(k) K143075

Substantially Equivalent

Tosoh Bioscience, Inc.

FDA 510(k) clearance K143075 for ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set, Substantially Equivalent on 2015-07-02. Applicant: Tosoh Bioscience, Inc..

Clearance details

Applicant: Tosoh Bioscience, Inc.
Product code: Code CDZ
Advisory panel: Clinical Chemistry
Date received: 2014-10-27
Decision date: 2015-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South San Franciso, CA, US

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