FDA 510(k) Application Details - K240242

Device Classification Name	Kit, Test, Pregnancy, Hcg, Over The Counter   More FDA Info for this Device
510(K) Number	K240242
Device Name	Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant	Anhui DEEPBLUE Medical Technology Co. LTD. No.777 Jimingshan Road, High-Tech Development Zone Hefei 230088 CN Other 510(k) Applications for this Company
Contact	Fengling Cheng 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	01/30/2024
Decision Date	10/11/2024
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