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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
Applicant
DIAGNOSTIC CHEMICALS LTD.
16 MCCARVILLE ST.
CHARLOTTETOWN,  CA C1E 2A6
Applicant Contact NANCY OLSCAMP
Correspondent
DIAGNOSTIC CHEMICALS LTD.
16 MCCARVILLE ST.
CHARLOTTETOWN,  CA C1E 2A6
Correspondent Contact NANCY OLSCAMP
Regulation Number862.1150
Classification Product Code
JIX  
Date Received09/24/2001
Decision Date 12/18/2001
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
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