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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
510(k) Number K923060
Device Name IQ IMMUNOCHEMISTRY SISTEM; IQ TSH 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 Number862.2160
Classification Product Code
JJE  
Date Received06/25/1992
Decision Date 09/15/1992
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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