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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, thyroxine-binding globulin
510(k) Number K861735
Device Name TIPSEP-TBG ASSAY
Applicant
NUCLEAR DIAGNOSTICS, INC.
575 ROBBINS DR.
TROY,  MI  48083
Applicant Contact SMART, PHD
Correspondent
NUCLEAR DIAGNOSTICS, INC.
575 ROBBINS DR.
TROY,  MI  48083
Correspondent Contact SMART, PHD
Regulation Number862.1685
Classification Product Code
CEE  
Date Received05/06/1986
Decision Date 06/13/1986
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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