FDA 510(k) Application Details - K970357

Device Classification Name	More FDA Info for this Device
510(K) Number	K970357
Device Name	EPISCREEN
Applicant	EPITOPE, INC. 8505 S.W. CREEKSIDE PLACE BEAVERTON, OR 97008 US Other 510(k) Applications for this Company
Contact	CAROLINE R SAYRE, RAC Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PJD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/30/1997
Decision Date	03/10/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review