VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126

Device Classification Name

calibrators, drug mixture

510(k) Number K033879
Device Name VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126
Applicant
MAINE STANDARDS CO.
765 roosevelt trail
suite 9a
windham, 
ME 
04062 -5365

Applicant Contact christine beach
Correspondent
MAINE STANDARDS CO.
765 roosevelt trail
suite 9a
windham, 
ME 
04062 -5365

Correspodent Contact christine beach
Regulation Number 862.3200
Classification Product Code
DKB  
Date Received 12/15/2003
Decision Date 02/27/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No