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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Parathyroid Hormone
510(k) Number K103325
Device Name IDS-ISYS INTACT PTH
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 Number862.1545
Classification Product Code
CEW  
Subsequent Product Codes
JIT   JJX  
Date Received11/12/2010
Decision Date 02/03/2012
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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