FDA 510(k) Application Details - K234081

Device Classification Name	Lancet, Blood   More FDA Info for this Device
510(K) Number	K234081
Device Name	Lancet, Blood
Applicant	RedDrop Dx 2401 Research Blvd, #206 Fort Collins, CO 80526 US Other 510(k) Applications for this Company
Contact	Kris Buchanan 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	12/22/2023
Decision Date	03/21/2024
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