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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k070009 B. Purpose for Submission: This submission is for the addition of four new analytes intended
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What is k070009-ccbdoc - accessdata fda?
k070009-ccbdoc - accessdata fda is a unique identifier assigned by the FDA to a specific product or application.
Who is required to file k070009-ccbdoc - accessdata fda?
The manufacturer or sponsor of the product or application is required to file k070009-ccbdoc - accessdata fda.
How to fill out k070009-ccbdoc - accessdata fda?
k070009-ccbdoc - accessdata fda can be filled out online through the FDA's electronic submission portal.
What is the purpose of k070009-ccbdoc - accessdata fda?
The purpose of k070009-ccbdoc - accessdata fda is to provide the FDA with detailed information about a specific product or application.
What information must be reported on k070009-ccbdoc - accessdata fda?
Information such as product ingredients, manufacturing process, labeling, and intended use must be reported on k070009-ccbdoc - accessdata fda.
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