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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 K081103
Device Name LOCI THYROID CALIBRATOR WITH MODEL RC610
Original Applicant
SIEMENS HEALTHCARE DIAGNOSTICS INC.
po box 6101
mailbox 514
newark,  DE  19714 6101
Original Contact yuk-ting lewis
Regulation Number862.1150
Classification Product Code
JIX  
Date Received04/18/2008
Decision Date 05/23/2008
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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