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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 K123703
Device Name HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE)
Applicant
HEALGEN SCIENTIFIC, LLC
3818 FUQUA STREET
HOUSTON,  TX  77401
Applicant Contact BRYAN FANG
Correspondent
HEALGEN SCIENTIFIC, LLC
3818 FUQUA STREET
HOUSTON,  TX  77401
Correspondent Contact BRYAN FANG
Regulation Number862.1155
Classification Product Code
LCX  
Date Received12/03/2012
Decision Date 04/10/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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