FDA 510(k) Application Details - K111143

Device Classification Name	Diazo Colorimetry, Bilirubin   More FDA Info for this Device
510(K) Number	K111143
Device Name	Diazo Colorimetry, Bilirubin
Applicant	POLYMEDCO, INC. 510 FURNACE DOCK RD. CORTLANDT MANOR, NY 10567 US Other 510(k) Applications for this Company
Contact	HELEN LANDICHO Other 510(k) Applications for this Contact
Regulation Number	862.1110   More FDA Info for this Regulation Number
Classification Product Code	CIG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/22/2011
Decision Date	09/01/2011
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