VALIDATE URINE CHEMISTRY CALIBRATION VERIFICATION TEST SETS


Device Classification Name

multi-analyte controls, all kinds (assayed)

510(k) Number K050504
Device Name VALIDATE URINE CHEMISTRY CALIBRATION VERIFICATION TEST SETS
Applicant
MAINE STANDARDS CO.
765 roosevelt trail
windham, 
ME 
04062 -5365

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

Correspodent Contact chirstine beach
Regulation Number 862.1660
Classification Product Code
JJY  
Date Received 02/28/2005
Decision Date 03/25/2005
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