SMS GLUCOSE CONTROL, MODEL 2120059

Device Classification Name

multi-analyte controls, all kinds (assayed)

510(k) Number K071433
Device Name SMS GLUCOSE CONTROL, MODEL 2120059
Applicant
SPECIALTY MEDICAL SUPPLIES
940 crossroads blvd.
seguin, 
TX 
78155

Applicant Contact john c gormley
Correspondent
SPECIALTY MEDICAL SUPPLIES
940 crossroads blvd.
seguin, 
TX 
78155

Correspodent Contact john c gormley
Regulation Number 862.1660
Classification Product Code
JJY  
Date Received 05/23/2007
Decision Date 06/28/2007
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