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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 K024337
Device Name GENERAL SEMEN ANALYSIS (GSA) KIT
Applicant
Bioshaf , Ltd.
16809 Briardale Rd.
Rockville,  MD  20855
Applicant Contact TOM TSAKERIS
Correspondent
Bioshaf , Ltd.
16809 Briardale Rd.
Rockville,  MD  20855
Correspondent Contact TOM TSAKERIS
Regulation Number864.5220
Classification Product Code
POV  
Date Received12/27/2002
Decision Date 07/03/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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