FDA 510(k) Application Details - K112790

Device Classification Name	Urinary Homocystine (Nonquantitative) Test System   More FDA Info for this Device
510(K) Number	K112790
Device Name	Urinary Homocystine (Nonquantitative) Test System
Applicant	AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK LUNA PLACE DUNDEE, DD2 1XA GB Other 510(k) Applications for this Company
Contact	KAREN HILL 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	09/26/2011
Decision Date	05/07/2012
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