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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 K032002
Device Name FERTELL FEMALE FERTILITY TEST
Applicant
Genosis, Inc.
1111 Pennsylvania Ave., NW
Washington,  DC  20004
Applicant Contact SHARON A SEGAL
Correspondent
Genosis, Inc.
1111 Pennsylvania Ave., NW
Washington,  DC  20004
Correspondent Contact SHARON A SEGAL
Regulation Number862.1300
Classification Product Code
NGA  
Date Received06/27/2003
Decision Date 10/30/2003
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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