FDA 510(k) Application Details - K203833

Device Classification Name	Enzyme Immunoassay, Tracrolimus   More FDA Info for this Device
510(K) Number	K203833
Device Name	Enzyme Immunoassay, Tracrolimus
Applicant	Shanghai Genext Medical Technology Co., Ltd. Rm1101, 11th Floor, Bldg 2, Pujiang Hi-Tech Plaza, No.2388 Chenhang Rd Pujiang Town Shanghai 201114 CN Other 510(k) Applications for this Company
Contact	Kimmy Zong Other 510(k) Applications for this Contact
Regulation Number	862.1678   More FDA Info for this Regulation Number
Classification Product Code	MLM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/30/2020
Decision Date	01/27/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review