FDA 510(k) Application Details - K133474

Device Classification Name	More FDA Info for this Device
510(K) Number	K133474
Device Name	BIOSIGN FLU A + B, STATUS FLU A & B
Applicant	PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 MONMOUTH JUNCTION, NJ 08852-1905 US Other 510(k) Applications for this Company
Contact	KYUNG-AH KIM Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PSZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/2013
Decision Date	12/10/2013
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