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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 K895186
Device Name FIAGEN T3 UPTAKE CATALOGUE #101-402
Applicant
Cyberfluor, Inc.
179 John St., 4th Floor ,
Toronto
Ontario M5t 1x4,  CA
Applicant Contact JAMES CLELLAND
Correspondent
Cyberfluor, Inc.
179 John St., 4th Floor ,
Toronto
Ontario M5t 1x4,  CA
Correspondent Contact JAMES CLELLAND
Regulation Number862.1715
Classification Product Code
KHQ  
Date Received08/11/1989
Decision Date 11/08/1989
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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