FDA 510(k) Application Details - K030045

Device Classification Name	Colorimetry, Cholinesterase   More FDA Info for this Device
510(K) Number	K030045
Device Name	Colorimetry, Cholinesterase
Applicant	OLYMPUS AMERICA, INC. 3131 WEST ROYAL LN. IRVING, TX 75063-3104 US Other 510(k) Applications for this Company
Contact	MICHAEL CAMPBELL Other 510(k) Applications for this Contact
Regulation Number	862.3240   More FDA Info for this Regulation Number
Classification Product Code	DIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/06/2003
Decision Date	02/21/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review