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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Visual, Pregnancy Hcg, Prescription Use
510(k) Number K043385
Device Name OSOM HCG COMBO TEST
Applicant
Genzyme Diagnostics
6659 Top Gun St.
San Diegi,  CA  92121
Applicant Contact E.V. GOORCHENKO
Correspondent
Genzyme Diagnostics
6659 Top Gun St.
San Diegi,  CA  92121
Correspondent Contact E.V. GOORCHENKO
Regulation Number862.1155
Classification Product Code
JHI  
Date Received12/09/2004
Decision Date 04/12/2005
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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