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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
510(k) Number K874866
Device Name T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE
Applicant
Serono Diagnostics, Inc.
100 Longwater Cir.
Norwell,  MA  02061
Applicant Contact PHILIP M FANTASIA
Correspondent
Serono Diagnostics, Inc.
100 Longwater Cir.
Norwell,  MA  02061
Correspondent Contact PHILIP M FANTASIA
Regulation Number862.1700
Classification Product Code
KLI  
Date Received11/27/1987
Decision Date 02/11/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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