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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 K925132
Device Name BECTON DICKINSON THYROID STIMULATING HORMONE SYSTE
Applicant
Becton Dickinson Advanced Diagnostics
10 Loveton Cir.
Sparks,  MD  21152
Applicant Contact JUDITH J SMITH
Correspondent
Becton Dickinson Advanced Diagnostics
10 Loveton Cir.
Sparks,  MD  21152
Correspondent Contact JUDITH J SMITH
Regulation Number862.1690
Classification Product Code
JLW  
Date Received10/13/1992
Decision Date 12/28/1992
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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