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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT C O M BIN A TO N TEMPLATE. 510(k) Number: k122435 B. Purpose for Submission: Extension of indication for used to

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Number k may be needed by individuals or organizations who are involved in statutory reporting, financial calculations, or documentation processes. It can be required by accountants, tax professionals, financial analysts, government agencies, or any other individuals or entities that require numerical information for legal or administrative purposes.

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