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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, total thyroxine
510(k) Number K782109
Device Name RIA KIT, GAMMACOAT
Applicant
CLINICAL ASSAYS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
CLINICAL ASSAYS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number862.1700
Classification Product Code
CDX  
Date Received12/19/1978
Decision Date 01/26/1979
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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