FDA 510(k) Application Details - K964315

Device Classification Name	Kit, Screening, Staphylococcus Aureus   More FDA Info for this Device
510(K) Number	K964315
Device Name	Kit, Screening, Staphylococcus Aureus
Applicant	REMEL, L.P. P.O. BOX 16276 AUGUSTA, GA 30919-2276 US Other 510(k) Applications for this Company
Contact	DAVID A WALL Other 510(k) Applications for this Contact
Regulation Number	866.2660   More FDA Info for this Regulation Number
Classification Product Code	JWX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/29/1996
Decision Date	02/07/1997
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