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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 K964155
Device Name CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST
Applicant
Genzyme Diagnostics
1531 Industrial Rd.
San Carlos,  CA  94070
Applicant Contact DELIA R BETHELL
Correspondent
Genzyme Diagnostics
1531 Industrial Rd.
San Carlos,  CA  94070
Correspondent Contact DELIA R BETHELL
Regulation Number862.1155
Classification Product Code
JHI  
Date Received10/16/1996
Decision Date 11/25/1996
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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