FDA 510(k) Application Details - K965149

Device Classification Name	Culture Media, Non-Propagating Transport   More FDA Info for this Device
510(K) Number	K965149
Device Name	Culture Media, Non-Propagating Transport
Applicant	REMEL CO. 12076 SANTA FE DR. LENEXA, KS 66215 US Other 510(k) Applications for this Company
Contact	MARY ANN SILVIUS Other 510(k) Applications for this Contact
Regulation Number	866.2390   More FDA Info for this Regulation Number
Classification Product Code	JSM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/1996
Decision Date	01/22/1997
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