FDA 510(k) Application Details - K052092

Device Classification Name	Antigens, Cf (Including Cf Control), Adenovirus 1-33   More FDA Info for this Device
510(K) Number	K052092
Device Name	Antigens, Cf (Including Cf Control), Adenovirus 1-33
Applicant	RAPID PATHOGEN SCREENING 13946 WOOD DUCK CIRCLE BRADENTON, FL 34202 US Other 510(k) Applications for this Company
Contact	ROBERT SAMBURSKY Other 510(k) Applications for this Contact
Regulation Number	866.3020   More FDA Info for this Regulation Number
Classification Product Code	GOD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/02/2005
Decision Date	11/22/2005
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