VALIDATE CHEM 9 CALIBRATION VERIFICATION TEST SET, MODEL 109


Device Classification Name

multi-analyte controls, all kinds (assayed)

510(k) Number K023352
Device Name VALIDATE CHEM 9 CALIBRATION VERIFICATION TEST SET, MODEL 109
Original Applicant
MAINE STANDARDS CO.
765 roosevelt trail
suite 9a
windham, 
ME 
04062 -5365

Original Contact christine beach
Regulation Number 862.1660
Classification Product Code
JJY  
Date Received 10/07/2002
Decision Date 11/22/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No