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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k052789 B. Purpose for Submission: Modification to the Triage BNP Test for the Beckman Coulter Immunoassay Systems

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What is modification to form triage?

Modification to form triage is a document used to make changes or updates to the initial triage form.

Who is required to file modification to form triage?

Any individual or entity who needs to update information on the initial triage form is required to file modification to form triage.

How to fill out modification to form triage?

To fill out modification to form triage, one must provide the updated information and any additional details necessary for the modification.

What is the purpose of modification to form triage?

The purpose of modification to form triage is to ensure that accurate and up-to-date information is recorded regarding the initial triage assessment.

What information must be reported on modification to form triage?

The information reported on modification to form triage should include the changes being made and any relevant details to support the modifications.

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