FDA 510(k) Application Details - K062862

Device Classification Name	Acid, Uric, Uricase (Colorimetric)   More FDA Info for this Device
510(K) Number	K062862
Device Name	Acid, Uric, Uricase (Colorimetric)
Applicant	OLYMPUS AMERICA, INC. 3131 WEST ROYAL LN. IRVING, TX 75063-3104 US Other 510(k) Applications for this Company
Contact	BEV HARDING Other 510(k) Applications for this Contact
Regulation Number	862.1775   More FDA Info for this Regulation Number
Classification Product Code	KNK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/25/2006
Decision Date	04/06/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review