FDA 510(k) Application Details - K954986

Device Classification Name	Culture Media, For Isolation Of Pathogenic Neisseria   More FDA Info for this Device
510(K) Number	K954986
Device Name	Culture Media, For Isolation Of Pathogenic Neisseria
Applicant	REMEL, L.P. 12076 SANTA FE DR. LENEXA, KS 66215-3594 US Other 510(k) Applications for this Company
Contact	MARY ANN SILVIUS Other 510(k) Applications for this Contact
Regulation Number	866.2410   More FDA Info for this Regulation Number
Classification Product Code	JTY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/31/1995
Decision Date	02/16/1996
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