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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name single (specified) analyte controls (assayed and unassayed)
510(k) Number K122141
Device Name IDS-ISYS IGF-I CALIBRATION VERIFIERS
Original Applicant
IMMUNODIAGNOSTIC SYSTEMS LTD.
10 didcot way,
bolden business park
boldon, tyne & wear,  UK ne35 9pd
Original Contact mick fenton
Regulation Number862.1660
Classification Product Code
JJX  
Date Received07/19/2012
Decision Date 08/07/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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