FDA 510(k) Application Details - K151742

Device Classification Name	Single (Specified) Analyte Controls (Assayed And Unassayed)   More FDA Info for this Device
510(K) Number	K151742
Device Name	Single (Specified) Analyte Controls (Assayed And Unassayed)
Applicant	BAYER HEALTHCARE 430 SOUTH BEIGER STREET MISHAWAKA, IN 46544 US Other 510(k) Applications for this Company
Contact	JENNIFER L. GREGORY 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	06/29/2015
Decision Date	09/23/2015
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