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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Human Chorionic Gonadotropin
510(k) Number K000844
Device Name ABSOLUTE HCG PREGNANCY TEST
Applicant
MIZUHO USA, INC.
6730 MESA RIDGE RD., SUITE D
SAN DIEGO,  CA  92121
Applicant Contact BENEDICT ZIN
Correspondent
MIZUHO USA, INC.
6730 MESA RIDGE RD., SUITE D
SAN DIEGO,  CA  92121
Correspondent Contact BENEDICT ZIN
Regulation Number862.1155
Classification Product Code
DHA  
Date Received03/15/2000
Decision Date 06/16/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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