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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioassay, Triiodothyronine Uptake
510(k) Number K810212
Device Name DAC-CEL T3 UPTAKE
Applicant
Burroughs Wellcome Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Burroughs Wellcome Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1715
Classification Product Code
KHQ  
Date Received01/27/1981
Decision Date 02/10/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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