FDA 510(k) Application Details - K112356

Device Classification Name	Single (Specified) Analyte Controls (Assayed And Unassayed)   More FDA Info for this Device
510(K) Number	K112356
Device Name	Single (Specified) Analyte Controls (Assayed And Unassayed)
Applicant	BIONOSTICS, INC. 7 JACKSON RD. DEVENS, MA 01434 US Other 510(k) Applications for this Company
Contact	RANDY BYRD Other 510(k) Applications for this Contact
Regulation Number	862.1660   More FDA Info for this Regulation Number
Classification Product Code	JJX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/16/2011
Decision Date	09/19/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review