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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 K111938
Device Name IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL...
Applicant
Immunodiagnostic Systems , Ltd.
10 Didcot Way,
Bolden Business Park
Boldon, Tyne & Wear,  GB NE35 9PD
Applicant Contact MICK FENTON
Correspondent
Immunodiagnostic Systems , Ltd.
10 Didcot Way,
Bolden Business Park
Boldon, Tyne & Wear,  GB NE35 9PD
Correspondent Contact MICK FENTON
Regulation Number862.1660
Classification Product Code
JJX  
Date Received07/08/2011
Decision Date 02/14/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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