FDA 510(k) Application Details - K965116

Device Classification Name	Radioimmunoassay, Human Chorionic Gonadotropin   More FDA Info for this Device
510(K) Number	K965116
Device Name	Radioimmunoassay, Human Chorionic Gonadotropin
Applicant	ABBOTT LABORATORIES DEPT. 389, AP30 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064-3537 US Other 510(k) Applications for this Company
Contact	KAREN L GATES 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	12/20/1996
Decision Date	02/20/1997
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