FDA 510(k) Application Details - K223289

Device Classification Name	Radioassay, Vitamin B12   More FDA Info for this Device
510(K) Number	K223289
Device Name	Radioassay, Vitamin B12
Applicant	Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318-1084 US Other 510(k) Applications for this Company
Contact	Kuljeet Kaur Other 510(k) Applications for this Contact
Regulation Number	862.1810   More FDA Info for this Regulation Number
Classification Product Code	CDD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/25/2022
Decision Date	12/23/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review