Tacrolimus Assay Kit— 510(k) K203833

Substantially Equivalent

Shanghai Genext Medical Technology Co., Ltd.

FDA 510(k) clearance K203833 for Tacrolimus Assay Kit, Substantially Equivalent on 2023-01-27. Applicant: Shanghai Genext Medical Technology Co., Ltd..

Clearance details

Applicant: Shanghai Genext Medical Technology Co., Ltd.
Product code: Code MLM
Advisory panel: Clinical Chemistry
Date received: 2020-12-30
Decision date: 2023-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

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