FDA 510(k) Application Details - K955266

Device Classification Name	Radioimmunoassay, Human Chorionic Gonadotropin   More FDA Info for this Device
510(K) Number	K955266
Device Name	Radioimmunoassay, Human Chorionic Gonadotropin
Applicant	BOEHRINGER MANNHEIM ITALIA SPA 1420 LOS ANGELES AVE. SUITE 201 SIMI VALLEY, CA 93065 US Other 510(k) Applications for this Company
Contact	CLEVE W LAIR Other 510(k) Applications for this Contact
Regulation Number	862.1155   More FDA Info for this Regulation Number
Classification Product Code	JHI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/15/1995
Decision Date	02/29/1996
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