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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 K926356
Device Name PRECISE(TM) HCG(URINE/SERUM) AND PRCISE(TM) PREG
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 Number862.1155
Classification Product Code
JHI  
Date Received12/21/1992
Decision Date 03/18/1993
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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