FDA 510(k) Application Details - K961487

Device Classification Name	System, Test, Human Chorionic Gonadotropin   More FDA Info for this Device
510(K) Number	K961487
Device Name	System, Test, Human Chorionic Gonadotropin
Applicant	BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. P.O. BOX 4117 CONCORD, CA 94524-4117 US Other 510(k) Applications for this Company
Contact	MARY KONING 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	04/18/1996
Decision Date	06/12/1996
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