FDA 510(k) Application Details - K131189

Device Classification Name	Hexokinase, Glucose   More FDA Info for this Device
510(K) Number	K131189
Device Name	Hexokinase, Glucose
Applicant	BECKMAN COULTER, INC. 250 S. KRAEMER ST BREA, CA 92821 US Other 510(k) Applications for this Company
Contact	Yvette Lloyd Other 510(k) Applications for this Contact
Regulation Number	862.1345   More FDA Info for this Regulation Number
Classification Product Code	CFR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/26/2013
Decision Date	04/17/2014
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