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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Semen Analysis Device
510(k) Number K915229
Device Name SEMEN ANALYSIS KIT
Applicant
Humagen Fertility Diagnostics, Inc.
2345 Hunter'S Way #2
Charlottesville,  VA  22901
Applicant Contact DEBRA BRYANT
Correspondent
Humagen Fertility Diagnostics, Inc.
2345 Hunter'S Way #2
Charlottesville,  VA  22901
Correspondent Contact DEBRA BRYANT
Regulation Number864.5220
Classification Product Code
POV  
Date Received11/20/1991
Decision Date 08/30/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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