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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 K884201
Device Name FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT
Applicant
CYBERFLUOR, INC.
179 JOHN ST., 4TH FL.,
TORONTO
ONTARIO M5T 1X4,  CA
Applicant Contact JAMES CLELLAND
Correspondent
CYBERFLUOR, INC.
179 JOHN ST., 4TH FL.,
TORONTO
ONTARIO M5T 1X4,  CA
Correspondent Contact JAMES CLELLAND
Regulation Number862.1685
Classification Product Code
CEE  
Date Received10/06/1988
Decision Date 12/14/1988
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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