FDA 510(k) Application Details - K954784

Device Classification Name	Test Reagents, Neisseria Gonorrhoeae Biochemical   More FDA Info for this Device
510(K) Number	K954784
Device Name	Test Reagents, Neisseria Gonorrhoeae Biochemical
Applicant	DIFCO LABORATORIES, INC. 17197 N. LAUREL PARK SUITE 400 LIVOUIA, MI 48152 US Other 510(k) Applications for this Company
Contact	DAVID W GATES Other 510(k) Applications for this Contact
Regulation Number	866.2660   More FDA Info for this Regulation Number
Classification Product Code	LTS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/17/1995
Decision Date	01/30/1996
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