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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 K941878
Device Name OCTEIA INTACT PTH
Applicant
I.D.S.
BOLDON BUSINESS PARK
TYNE & WEAR,  GB NE35 9PD
Applicant Contact ANITA GROUNDWATER
Correspondent
I.D.S.
BOLDON BUSINESS PARK
TYNE & WEAR,  GB NE35 9PD
Correspondent Contact ANITA GROUNDWATER
Regulation Number862.1545
Classification Product Code
CEW  
Date Received04/18/1994
Decision Date 09/07/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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