VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601


Device Classification Name

multi-analyte controls, all kinds (assayed)

510(k) Number K072246
Device Name VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601
Applicant
MAINE STANDARDS CO.
765 roosevelt trail
windham, 
ME 
04062 -5365

Applicant Contact holly cressman
Correspondent
MAINE STANDARDS CO.
765 roosevelt trail
windham, 
ME 
04062 -5365

Correspodent Contact holly cressman
Regulation Number 862.1660
Classification Product Code
JJY  
Date Received 08/13/2007
Decision Date 09/14/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Immunology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No