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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 K955097
Device Name AMERLITE MAB FT4 ASSAY
Applicant
Kodak Clinical Diagnostics, Ltd.
Nightingales Ln.
Chalfont St. Giles
Buckinghamshire,  GB HP84SP
Applicant Contact SARAH CLARK
Correspondent
Kodak Clinical Diagnostics, Ltd.
Nightingales Ln.
Chalfont St. Giles
Buckinghamshire,  GB HP84SP
Correspondent Contact SARAH CLARK
Regulation Number862.1695
Classification Product Code
CEC  
Subsequent Product Code
JIS  
Date Received11/07/1995
Decision Date 12/20/1995
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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