FDA 510(k) Application Details - K072827

Device Classification Name	Culture Media, Antifungal, Susceptibility Test   More FDA Info for this Device
510(K) Number	K072827
Device Name	Culture Media, Antifungal, Susceptibility Test
Applicant	REMEL, INC. 12076 SANTA FE DR. LENEXA, KS 66215 US Other 510(k) Applications for this Company
Contact	Andre Hsiung Other 510(k) Applications for this Contact
Regulation Number	866.1700   More FDA Info for this Regulation Number
Classification Product Code	MJE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/03/2007
Decision Date	11/26/2007
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