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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name radioimmunoassay, free thyroxine
510(k) Number K781012
Device Name RIA TEST KIT SYS. DAMON KIQUISOL FREE
Applicant
DAMON CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
DAMON CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1695
Classification Product Code
CEC  
Date Received06/16/1978
Decision Date 07/27/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
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