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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 K864658
Device Name IQ FREE T4 IMMUNOASSAY
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1 BECTON DR.
FRANKLIN LAKES,  NJ  07417 -1880
Applicant Contact RUSSELL ARNSBERGER
Correspondent
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1 BECTON DR.
FRANKLIN LAKES,  NJ  07417 -1880
Correspondent Contact RUSSELL ARNSBERGER
Regulation Number862.1695
Classification Product Code
CEC  
Date Received11/28/1986
Decision Date 03/12/1987
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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