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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k112870 B. Purpose for Submission: New device C. Measured: Human chorionic (HCG) D. Type of Test:

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What is assay only template?

Assay only template is a form used to report specific data related to a particular assay.

Who is required to file assay only template?

Any individual or organization conducting the assay and generating the data is required to file the assay only template.

How to fill out assay only template?

The assay only template can be filled out by providing all the required information in the designated sections of the form.

What is the purpose of assay only template?

The purpose of the assay only template is to document and report the results of a specific assay in a standardized format.

What information must be reported on assay only template?

Information such as date of assay, type of assay, results of the assay, and any relevant notes must be reported on the assay only template.

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