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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 K013194
Device Name UNIMARK HCG COMBO PREGNANCY TEST
Applicant
Biotech Atlantic, Inc.
Bay F, 6 Industrial Way W.
Eatontown,  NJ  07724
Applicant Contact FRANCIS LEE
Correspondent
Biotech Atlantic, Inc.
Bay F, 6 Industrial Way W.
Eatontown,  NJ  07724
Correspondent Contact FRANCIS LEE
Regulation Number862.1155
Classification Product Code
JHI  
Date Received09/25/2001
Decision Date 10/10/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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