FDA 510(k) Application Details - K130020

Device Classification Name	System, Test, Human Chorionic Gonadotropin   More FDA Info for this Device
510(K) Number	K130020
Device Name	System, Test, Human Chorionic Gonadotropin
Applicant	BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318-1084 US Other 510(k) Applications for this Company
Contact	GERALDINE L BAGLIEN Other 510(k) Applications for this Contact
Regulation Number	862.1155   More FDA Info for this Regulation Number
Classification Product Code	DHA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/03/2013
Decision Date	10/01/2013
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