FDA 510(k) Application Details - K220608

Device Classification Name	More FDA Info for this Device
510(K) Number	K220608
Device Name	Accu-Chek FastClix Blood Lancing System
Applicant	Roche Diabetes Care, Inc 9115 Hague Road Indianapolis, IN 46250 US Other 510(k) Applications for this Company
Contact	Thomas Kristen Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QRL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/02/2022
Decision Date	04/29/2022
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