FDA 510(k) Application Details - K242388

Device Classification Name	More FDA Info for this Device
510(K) Number	K242388
Device Name	LensHooke X12 PRO Semen Analysis System
Applicant	Bonraybio Co., LTD. 4F., No. 118, Gongye 9th Rd., Dali Dist. Taichung 41280 TW Other 510(k) Applications for this Company
Contact	Clare Huang Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	POV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/12/2024
Decision Date	05/09/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review