FDA 510(k) Application Details - K936111

Device Classification Name	Lambda, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K936111
Device Name	Lambda, Antigen, Antiserum, Control
Applicant	BIOTEK SOLUTIONS, INC. 120 B CREMONA DR. SANTA BARBARA, CA 93117 US Other 510(k) Applications for this Company
Contact	ELLIOTT FRIEDMAN Other 510(k) Applications for this Contact
Regulation Number	866.5550   More FDA Info for this Regulation Number
Classification Product Code	DEH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/1993
Decision Date	02/27/1996
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