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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Follicle Stimulating Hormone (Fsh), Over The Counter
510(k) Number K070484
Device Name QUANTRX FEMALE FERTILITY TEST
Applicant
Quantrx Biomedical Corporation
14033 Stoney Gate Pl.
San Diego,  CA  92128
Applicant Contact LORRAINE C COGAN
Correspondent
Quantrx Biomedical Corporation
14033 Stoney Gate Pl.
San Diego,  CA  92128
Correspondent Contact LORRAINE C COGAN
Regulation Number862.1300
Classification Product Code
NGA  
Date Received02/20/2007
Decision Date 10/22/2007
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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