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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 K943859
Device Name QUICK CHECKER HCG PREGNANCY TEST
Applicant
Mizuho USA, Inc.
5555 Oberlin Dr.
Suite 120
San Diego,  CA  92121
Applicant Contact BENEDICT ZIN
Correspondent
Mizuho USA, Inc.
5555 Oberlin Dr.
Suite 120
San Diego,  CA  92121
Correspondent Contact BENEDICT ZIN
Regulation Number862.1155
Classification Product Code
JHI  
Date Received08/08/1994
Decision Date 02/10/1995
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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