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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Screening, Trichomonas
510(k) Number K033864
Device Name GENZYME OSOM TRICHOMONAS RAPID TEST
Applicant
Genzyme Corp.
One Kendall Sq.
Cambridge,  MA  02139
Applicant Contact E.V. GOORCHENKO
Correspondent
Genzyme Corp.
One Kendall Sq.
Cambridge,  MA  02139
Correspondent Contact E.V. GOORCHENKO
Regulation Number866.2660
Classification Product Code
JWZ  
Date Received12/12/2003
Decision Date 04/02/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
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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