VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT


Device Classification Name

multi-analyte controls, all kinds (assayed)

510(k) Number K110880
Device Name VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT
Applicant
MAINE STANDARDS COMPANY, LLC
765 roosevelt trail
windham, 
ME 
04062

Applicant Contact holly cressman
Correspondent
MAINE STANDARDS COMPANY, LLC
765 roosevelt trail
windham, 
ME 
04062

Correspodent Contact holly cressman
Regulation Number 862.1660
Classification Product Code
JJY  
Date Received 03/30/2011
Decision Date 07/05/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No