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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 K023544
Device Name GENZYME CONTRAST II HCG URINE/SERUM TEST
Applicant
Genzyme Corp.
One Kendall Square
Cambridge,  MA  02139
Applicant Contact E.V. GOORCHENKO
Correspondent
Genzyme Corp.
One Kendall Square
Cambridge,  MA  02139
Correspondent Contact E.V. GOORCHENKO
Regulation Number862.1155
Classification Product Code
JHI  
Date Received10/22/2002
Decision Date 01/16/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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