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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE. 510(k) Number: k161954 B. Purpose for Submission: Addition of previously cleared test systems
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07
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08
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What is review memorandum k161954?
The review memorandum k161954 is a document that summarizes the review process for a specific case or situation.
Who is required to file review memorandum k161954?
The individual or organization responsible for conducting the review is required to file the review memorandum k161954.
How to fill out review memorandum k161954?
The review memorandum k161954 can be filled out by providing all required information and details about the review process and findings.
What is the purpose of review memorandum k161954?
The purpose of review memorandum k161954 is to document and communicate the results of the review process.
What information must be reported on review memorandum k161954?
The review memorandum k161954 must include details about the review process, findings, recommendations, and any actions taken.
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