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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Visual, Pregnancy Hcg, Prescription Use
510(k) Number K915197
Device Name PRECISE TM HCG
Applicant
Becton Dickinson Advanced Diagnostics
225 International Cir.
Cockeysville,  MD  21030
Applicant Contact JUDITH J SMITH
Correspondent
Becton Dickinson Advanced Diagnostics
225 International Cir.
Cockeysville,  MD  21030
Correspondent Contact JUDITH J SMITH
Regulation Number862.1155
Classification Product Code
JHI  
Date Received11/19/1991
Decision Date 12/17/1991
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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