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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Multi-Analyte Mixture
510(k) Number K023792
Device Name CALIBRATION PACK, MODELS A9100-101S AND A9100-103S
Applicant
Thermo Orion
500 Cummings Center
Beverly,  MA  01915
Applicant Contact PATRICK K CHIU
Correspondent
Thermo Orion
500 Cummings Center
Beverly,  MA  01915
Correspondent Contact PATRICK K CHIU
Regulation Number862.1150
Classification Product Code
JIX  
Date Received11/13/2002
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
Predetermined Change
Control Plan Authorized		 No
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