FDA 510(k) Application Details - K231832

Device Classification Name	Myoglobin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K231832
Device Name	Myoglobin, Antigen, Antiserum, Control
Applicant	Beckman Coulter, Inc 1000 Lake Hazeltine Drive Chaska, MN 55318 US Other 510(k) Applications for this Company
Contact	Kate Oelberg Other 510(k) Applications for this Contact
Regulation Number	866.5680   More FDA Info for this Regulation Number
Classification Product Code	DDR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/22/2023
Decision Date	09/18/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review