FDA 510(k) Application Details - K053196

Device Classification Name	Test, Albumin Cobalt Binding   More FDA Info for this Device
510(K) Number	K053196
Device Name	Test, Albumin Cobalt Binding
Applicant	INVERNESS MEDICAL INNOVATIONS, INC. 51 SAWYER RD., SUITE 200 WALTHAM, MA 02453-3448 US Other 510(k) Applications for this Company
Contact	JAMES M DELANEY Other 510(k) Applications for this Contact
Regulation Number	862.1215   More FDA Info for this Regulation Number
Classification Product Code	NJV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/16/2005
Decision Date	12/16/2005
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