FDA 510(k) Application Details - K213808

Device Classification Name	Kit, Test, Pregnancy, Hcg, Over The Counter   More FDA Info for this Device
510(K) Number	K213808
Device Name	Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant	Co-Innovation Biotech Co.,Ltd. No. 9 Baihe 3 Street, Economic And Technological Development East Zone Guangzhou 510507 CN Other 510(k) Applications for this Company
Contact	Hong Feng Other 510(k) Applications for this Contact
Regulation Number	862.1155   More FDA Info for this Regulation Number
Classification Product Code	LCX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/06/2021
Decision Date	04/05/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review