FDA 510(k) Application Details - K970833

Device Classification Name	Discs, Strips And Reagents, Microorganism Differentiation   More FDA Info for this Device
510(K) Number	K970833
Device Name	Discs, Strips And Reagents, Microorganism Differentiation
Applicant	REMEL, INC. 12076 SANTA FE DR. LENEXA, KS 66215-3594 US Other 510(k) Applications for this Company
Contact	MARY A SILVIUS Other 510(k) Applications for this Contact
Regulation Number	866.2660   More FDA Info for this Regulation Number
Classification Product Code	JTO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/07/1997
Decision Date	04/02/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review