FDA 510(k) Application Details - K242680

Device Classification Name	Lancet, Blood   More FDA Info for this Device
510(K) Number	K242680
Device Name	Lancet, Blood
Applicant	PrivaPath Diagnostics Ltd (dba LetsGetChecked) Unit 1, Northern Cross Business Park North Road, Dublin 11 Dublin D11XT26 IE Other 510(k) Applications for this Company
Contact	Karen Walsh Other 510(k) Applications for this Contact
Regulation Number	878.4800   More FDA Info for this Regulation Number
Classification Product Code	FMK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/06/2024
Decision Date	01/13/2025
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review