CARESIDE CHOLINESTERASE


information about

Device Classification Name

colorimetry, cholinesterase

510(k) Number K002792
Device Name CARESIDE CHOLINESTERASE
Original Applicant
CARESIDE, INC.
6100 bristol pkwy.
culver city, 
CA 
90230

Original Contact kenneth b asarch
Regulation Number 862.3240
Classification Product Code
DIH  
Date Received 09/07/2000
Decision Date 11/08/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Clinical Chemistry

Type Traditional
Reviewed by Third Party No

Combination Product

No