FDA 510(k) Application Details - K960075

Device Classification Name	Kit, Screening, Yeast   More FDA Info for this Device
510(K) Number	K960075
Device Name	Kit, Screening, Yeast
Applicant	HARDY DIAGNOSTICS 1430 WEST MCCOY LN. SANTA MARIA, CA 93455 US Other 510(k) Applications for this Company
Contact	MELISSA M TRAYLOR Other 510(k) Applications for this Contact
Regulation Number	866.2660   More FDA Info for this Regulation Number
Classification Product Code	JXC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/11/1996
Decision Date	08/02/1996
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