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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Test, Pregnancy, Hcg, Over The Counter
510(k) Number K914254
Device Name HOMECLINIC ONE STEP PREGNANCY TEST
Applicant
Vanguard Biomedical Corp.
7822 Convoy Ct.
San Diego,  CA  92111
Applicant Contact JOHN CHIU
Correspondent
Vanguard Biomedical Corp.
7822 Convoy Ct.
San Diego,  CA  92111
Correspondent Contact JOHN CHIU
Regulation Number862.1155
Classification Product Code
LCX  
Date Received09/23/1991
Decision Date 10/17/1991
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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