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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 K013178
Device Name DC-UIBC-CO2-CAL, MODEL SE-153
Original Applicant
16 mccarville st.
charlottetown,  CA c1e 2a6
Original Contact nancy olscamp
Regulation Number862.1150
Classification Product Code
Date Received09/24/2001
Decision Date 12/18/2001
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No