FDA 510(k) Application Details - K023677

Device Classification Name	Device, General Purpose, Microbiology, Diagnostic   More FDA Info for this Device
510(K) Number	K023677
Device Name	Device, General Purpose, Microbiology, Diagnostic
Applicant	OSMETECH ELECTRA HOUSE ELECTRA WAY CREWE GB Other 510(k) Applications for this Company
Contact	ANDREW TUMMON Other 510(k) Applications for this Contact
Regulation Number	866.2660   More FDA Info for this Regulation Number
Classification Product Code	LIB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/01/2002
Decision Date	01/29/2003
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