OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)


Device Classification Name

colorimetry, cholinesterase

510(k) Number K030045
Device Name OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)
Original Applicant
OLYMPUS AMERICA, INC.
3131 west royal ln.
irving, 
TX 
75063 -3104

Original Contact michael campbell
Regulation Number 862.3240
Classification Product Code
DIH  
Date Received 01/06/2003
Decision Date 02/21/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Clinical Chemistry

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No