CALIBRATION PACK, MODELS A9100-101S AND A9100-103S


Device Classification Name

calibrator, multi-analyte mixture

510(k) Number K023792
Device Name CALIBRATION PACK, MODELS A9100-101S AND A9100-103S
Original Applicant
THERMO ORION
500 cummings center
beverly, 
MA 
01915 -6199

Original Contact patrick k chiu
Regulation Number 862.1150
Classification Product Code
JIX  
Date Received 11/13/2002
Decision Date 01/31/2003
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