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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 K853006
Device Name HUMAN CHORIONIC GONAD TEST SYS FOR EARLY PREGNANCY
Applicant
Modern Diagnostics, Inc.
5859 Power Inn Rd.
Sacramento,  CA  95824
Applicant Contact ROBERT L BUCK
Correspondent
Modern Diagnostics, Inc.
5859 Power Inn Rd.
Sacramento,  CA  95824
Correspondent Contact ROBERT L BUCK
Regulation Number862.1155
Classification Product Code
JHI  
Date Received07/16/1985
Decision Date 09/04/1985
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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