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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Total Thyroxine
510(k) Number K931295
Device Name IQ TT4 ASSAY
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 Number862.1700
Classification Product Code
CDX  
Date Received03/15/1993
Decision Date 07/20/1993
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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