FDA 510(k) Application Details - K970931

Device Classification Name	Latex Agglutination Assay, Rubella   More FDA Info for this Device
510(K) Number	K970931
Device Name	Latex Agglutination Assay, Rubella
Applicant	SIENNA BIOTECH, INC. 9115 GUILFORD RD. SUITE 180 COLUMBIA, MD 21046-1893 US Other 510(k) Applications for this Company
Contact	JUDITH J SMITH Other 510(k) Applications for this Contact
Regulation Number	866.3510   More FDA Info for this Regulation Number
Classification Product Code	LQN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/07/1997
Decision Date	04/24/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review