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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 K041926
Device Name HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278
Original Applicant
DIAGNOSTIC CHEMICALS LTD.
16 mccarville st.
charlottetown, pe,  CA c1e 2a6
Original Contact nancy olscamp
Regulation Number862.1150
Classification Product Code
JIX  
Date Received07/19/2004
Decision Date 11/23/2004
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
statement statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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