Cleared Traditional

Tacrolimus Assay Kit

K203833 · Shanghai Genext Medical Technology Co., Ltd. · Chemistry

Jan 2023

Decision

758d

Days

Class 2

Risk

About This 510(k) Submission

K203833 is an FDA 510(k) clearance for the Tacrolimus Assay Kit, a Enzyme Immunoassay, Tracrolimus (Class II — Special Controls, product code MLM), submitted by Shanghai Genext Medical Technology Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on January 27, 2023, 758 days after receiving the submission on December 30, 2020. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1678.

Submission Details

510(k) Number	K203833 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 30, 2020
Decision Date	January 27, 2023
Days to Decision	758 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF