FDA 510(k) Application Details - K140496

Device Classification Name	Radioassay, Vitamin B12   More FDA Info for this Device
510(K) Number	K140496
Device Name	Radioassay, Vitamin B12
Applicant	BECKMAN COULTER, INC. 250 S. KRAEMER BLVD. MAIL STOP E1.SE.01 BREA, CA 92821 US Other 510(k) Applications for this Company
Contact	NANETTE CANEPA 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	02/27/2014
Decision Date	09/16/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review