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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name radioimmunoassay, thyroid-stimulating hormone
510(k) Number K760044
Device Name KIT, RIA, HUMAN THYROID HORMONE
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1875 EYE ST. NW STE. 625
washington,  DC  20006
Correspondent
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1875 EYE ST. NW STE. 625
washington,  DC  20006
Regulation Number862.1690
Classification Product Code
JLW  
Date Received06/15/1976
Decision Date 07/26/1976
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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