FDA 510(k) Application Details - K961191

Device Classification Name	Discs, Strips And Reagents, Microorganism Differentiation   More FDA Info for this Device
510(K) Number	K961191
Device Name	Discs, Strips And Reagents, Microorganism Differentiation
Applicant	HARDY DIAGNOSTICS 1430 WEST MCCOY LN. SANTA MARIA, CA 93455 US Other 510(k) Applications for this Company
Contact	MELISSA M TRAYLOR, RAC 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	03/26/1996
Decision Date	06/17/1996
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