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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 K894012
Device Name MINICLINIC PREGNANCY TEST
Applicant
Vanguard Biomedical Corp.
7822 Convoy Ct.
San Diego,  CA  92111
Applicant Contact CHIU, PH.D.
Correspondent
Vanguard Biomedical Corp.
7822 Convoy Ct.
San Diego,  CA  92111
Correspondent Contact CHIU, PH.D.
Regulation Number862.1155
Classification Product Code
JHI  
Date Received06/06/1989
Decision Date 07/25/1989
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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