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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK930640
Test Name BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC PRECISE PREGNANCY  
Manufacturer NameBd Becton Dickinson Vacutainer Systems Preanalytic
Consumer Information Phone NumberNO PHONE NUMBER
Test TypeUrine hCG by visual color comparison tests
Effective Date03/18/1993
Device Classification Name Kit, Test, Pregnancy, Hcg, Over The Counter
510(k) Number K930640
Device Name PRECISE PREGNANCY
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
10 Loveton Cir.
Sparks,  MD  21152
Applicant Contact JUDITH J SMITH
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
10 Loveton Cir.
Sparks,  MD  21152
Correspondent Contact JUDITH J SMITH
Regulation Number862.1155
Classification Product Code
LCX  
Date Received01/28/1993
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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