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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 K043231
Device Name PROOF POSITIVE ELECTRONIC PREGNANCY TEST
Applicant
Mizuho USA, Inc.
12131 Community Rd.
Poway,  CA  92064
Applicant Contact BENEDICT ZIN
Correspondent
Mizuho USA, Inc.
12131 Community Rd.
Poway,  CA  92064
Correspondent Contact BENEDICT ZIN
Regulation Number862.1155
Classification Product Code
LCX  
Date Received11/22/2004
Decision Date 04/25/2005
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
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