FDA 510(k) Application Details - K243898

Device Classification Name	Strip, Test, Reagent, Residuals For Dialysate, Disinfectant   More FDA Info for this Device
510(K) Number	K243898
Device Name	Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
Applicant	Nelson Environmental Technologies, Inc. 813 E. Fir Avenue McAllen, TX 78501 US Other 510(k) Applications for this Company
Contact	QuocHuy (Huy) Nguyen Other 510(k) Applications for this Contact
Regulation Number	876.5665   More FDA Info for this Regulation Number
Classification Product Code	MSY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/19/2024
Decision Date	04/11/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review