FDA 510(k) Application Details - K964407

Device Classification Name	System, Test, Immunological, Antigen, Tumor   More FDA Info for this Device
510(K) Number	K964407
Device Name	System, Test, Immunological, Antigen, Tumor
Applicant	ABBOTT LABORATORIES DEPT. 389, AP30 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064-3537 US Other 510(k) Applications for this Company
Contact	JOY C SONSALLA Other 510(k) Applications for this Contact
Regulation Number	866.6010   More FDA Info for this Regulation Number
Classification Product Code	MOI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/04/1996
Decision Date	11/10/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review