FDA 510(k) Application Details - K220364

Device Classification Name	Lancet, Blood   More FDA Info for this Device
510(K) Number	K220364
Device Name	Lancet, Blood
Applicant	Roche Diabetes Care, Inc. 9115 Hague Road Indianapolis, IN 46250 US Other 510(k) Applications for this Company
Contact	Julia Best 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	02/08/2022
Decision Date	04/05/2022
Decision	SESE - SUBST EQUIV
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