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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK051963
Test Name Natureplex, LLC BE CERTAIN Home Pregnancy Test  
Manufacturer NameNatureplex, LLC
Consumer Information Phone Number(866)323-0107
Test TypeUrine hCG by visual color comparison tests
Effective Date01/12/2007
Device Classification Name Kit, Test, Pregnancy, Hcg, Over The Counter
510(k) Number K051963
Device Name BE-CERTAIN PREGNANCY TEST
Applicant
Natureplex, LLC
3791 Airpark St.
Memphis,  TN  38118
Applicant Contact VICTOR J SANTOS
Correspondent
Natureplex, LLC
3791 Airpark St.
Memphis,  TN  38118
Correspondent Contact VICTOR J SANTOS
Regulation Number862.1155
Classification Product Code
LCX  
Date Received07/19/2005
Decision Date 11/23/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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