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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 K850987
Device Name MEDIX VISUAL SERUMO HCG L10/10 TEST HCG ENZYME IMM
Applicant
Medix Biotech, Inc.
1420 Stafford St.
Redwood City,  CA  94063
Applicant Contact SHAW J BIAN
Correspondent
Medix Biotech, Inc.
1420 Stafford St.
Redwood City,  CA  94063
Correspondent Contact SHAW J BIAN
Regulation Number862.1155
Classification Product Code
JHI  
Date Received03/11/1985
Decision Date 04/08/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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