FDA 510(k) Application Details - K101831

Device Classification Name	More FDA Info for this Device
510(K) Number	K101831
Device Name	ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800
Applicant	BIONOSTICS, INC. 7 JACKSON RD. DEVENS, MA 01434 US Other 510(k) Applications for this Company
Contact	MINNA RANNIKKO Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OSL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/01/2010
Decision Date	10/01/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review