VALIDATE CHEM 10 CALIBRATION VERIFICATION TEST SET, MODEL 110


Device Classification Name

multi-analyte controls, all kinds (assayed)

510(k) Number K023410
Device Name VALIDATE CHEM 10 CALIBRATION VERIFICATION TEST SET, MODEL 110
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 10/10/2002
Decision Date 01/06/2003
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