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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 K934012
Device Name FT4 RADIOIMMUNOASSAY
Applicant
Immunotech S.A.
13276 Marsille Cedex 9
France,  FR
Applicant Contact P. PRINCE
Correspondent
Immunotech S.A.
13276 Marsille Cedex 9
France,  FR
Correspondent Contact P. PRINCE
Regulation Number862.1695
Classification Product Code
CEC  
Date Received08/18/1993
Decision Date 11/16/1993
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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