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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k043231 B. Purpose for Submission: New Device C. Measured: Human chorionic D. Type of Test: Qualitative

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Mizuho USA Inc. is a subsidiary of Mizuho Financial Group, Inc., a Japanese financial services company.

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Mizuho USA Inc. is required to file financial reports with regulatory authorities and may also be required to file tax returns with the IRS.

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Mizuho USA Inc. can fill out the necessary forms and reports using the guidelines provided by the relevant regulatory authorities and accounting standards.

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The purpose of Mizuho USA Inc. is to conduct financial services activities, such as banking, securities, and investment banking, in the United States.

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Information such as financial statements, balance sheets, income statements, and other relevant financial data must be reported on Mizuho USA Inc. filings.

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