THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050


Device Classification Name

calibrator, multi-analyte mixture

510(k) Number K022108
Device Name THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050
Original Applicant
THERMO DMA, INC.
845 ave. g east
arlington, 
TX 
76011

Original Contact thomas dollar
Regulation Number 862.1150
Classification Product Code
JIX  
Date Received 06/28/2002
Decision Date 07/25/2002
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