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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 K942369
Device Name GAMMA-BCT INTACT PTH
Applicant
IMMUNODIAGNOSTIC SYSTEMS LTD.
BOLDEN BUSINESS PARK
BOLDON
TYNE AND WEAR,  GB NE35 9PD
Applicant Contact ANITA GROUNDWATER
Correspondent
IMMUNODIAGNOSTIC SYSTEMS LTD.
BOLDEN BUSINESS PARK
BOLDON
TYNE AND WEAR,  GB NE35 9PD
Correspondent Contact ANITA GROUNDWATER
Regulation Number862.1545
Classification Product Code
CEW  
Date Received05/18/1994
Decision Date 09/20/1994
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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