FDA 510(k) Application Details - K061575

Device Classification Name	Azo Dye, Calcium   More FDA Info for this Device
510(K) Number	K061575
Device Name	Azo Dye, Calcium
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	862.1145   More FDA Info for this Regulation Number
Classification Product Code	CJY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/07/2006
Decision Date	10/05/2006
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