FDA 510(k) Application Details - K123930

Device Classification Name	Urinary Homocystine (Nonquantitative) Test System   More FDA Info for this Device
510(K) Number	K123930
Device Name	Urinary Homocystine (Nonquantitative) Test System
Applicant	Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. ROCHESTER, NY 14626-5101 US Other 510(k) Applications for this Company
Contact	MICHAEL M BYRNE Other 510(k) Applications for this Contact
Regulation Number	862.1377   More FDA Info for this Regulation Number
Classification Product Code	LPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/20/2012
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	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review