FDA 510(k) Application Details - K130603

Device Classification Name	Calibrator, Secondary   More FDA Info for this Device
510(K) Number	K130603
Device Name	Calibrator, Secondary
Applicant	MITSUBISHI CHEMICAL MEDIENCE CORPORATION 2 BETHESDA METRO CENTER SUITE 850 BETHESDA, MD 20814 US Other 510(k) Applications for this Company
Contact	Judi Smith Other 510(k) Applications for this Contact
Regulation Number	862.1150   More FDA Info for this Regulation Number
Classification Product Code	JIT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/07/2013
Decision Date	03/27/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review