FDA 510(k) Application Details - K123586

Device Classification Name	Alkaline Picrate, Colorimetry, Creatinine   More FDA Info for this Device
510(K) Number	K123586
Device Name	Alkaline Picrate, Colorimetry, Creatinine
Applicant	MEDICA CORPORATION 5 OAK PARK DRIVE BEDFORD, MA 01730 US Other 510(k) Applications for this Company
Contact	Photios Makris Other 510(k) Applications for this Contact
Regulation Number	862.1225   More FDA Info for this Regulation Number
Classification Product Code	CGX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/21/2012
Decision Date	05/15/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review