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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 K922284
Device Name ELEGANCE FT4 ELISA
Applicant
BIOCLONE AUSTRALIA PTY LTD.
C/O BAKER & HOSTETLER
1050 CONNECTICUT AVE., N.W.,
STE 1100, WASHINGTON,  DC  20036
Applicant Contact BRUCE F MACKLER
Correspondent
BIOCLONE AUSTRALIA PTY LTD.
C/O BAKER & HOSTETLER
1050 CONNECTICUT AVE., N.W.,
STE 1100, WASHINGTON,  DC  20036
Correspondent Contact BRUCE F MACKLER
Regulation Number862.1695
Classification Product Code
CEC  
Date Received05/15/1992
Decision Date 07/10/1992
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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