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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
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 Received07/19/2012
Decision Date 08/07/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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