FDA 510(k) Application Details - K070522

Device Classification Name	Legionella, Spp., Elisa   More FDA Info for this Device
510(K) Number	K070522
Device Name	Legionella, Spp., Elisa
Applicant	INVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS 10 SOUTHGATE RD. SCARBOROUGH, ME 04074 US Other 510(k) Applications for this Company
Contact	KAREN MORTIMER Other 510(k) Applications for this Contact
Regulation Number	866.3300   More FDA Info for this Regulation Number
Classification Product Code	MJH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/23/2007
Decision Date	03/15/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review