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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., NW
Washington,  DC  20036
Applicant Contact BRUCE F MACKLER
Correspondent
Bioclone Australia Pty , Ltd.
C/O Baker & Hostetler
1050 Connecticut Ave., NW
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
Predetermined Change
Control Plan Authorized		 No
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