FDA 510(k) Application Details - K011043

Device Classification Name	Kit, Screening, Urine   More FDA Info for this Device
510(K) Number	K011043
Device Name	Kit, Screening, Urine
Applicant	OSMETECH ELECTRA HOUSE ELECTRA WAY CREWE CW1 6WZ GB Other 510(k) Applications for this Company
Contact	JOHN PLANT Other 510(k) Applications for this Contact
Regulation Number	866.2660   More FDA Info for this Regulation Number
Classification Product Code	JXA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/05/2001
Decision Date	11/30/2001
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