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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 K782103
Device Name RIA KIT, NEONATAL T4
Applicant
SERONO LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SERONO LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1700
Classification Product Code
CDX  
Date Received12/15/1978
Decision Date 01/17/1979
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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