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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 K842167
Device Name TBG RIA
Applicant
SYNCOR INTL. CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SYNCOR INTL. CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1685
Classification Product Code
CEE  
Date Received05/31/1984
Decision Date 07/09/1984
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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