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This document provides safety and effectiveness information for the LSI Multiple Analyte Sets A, B, and C, intended for calibration in toxicology assays.
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What is 510k summary of safety?
The 510(k) summary of safety is a document submitted to the FDA that outlines the safety and effectiveness of a medical device, demonstrating that it is substantially equivalent to a legally marketed device.
Who is required to file 510k summary of safety?
Manufacturers or importers of medical devices that are seeking to demonstrate substantial equivalence to an existing device are required to file a 510(k) summary of safety.
How to fill out 510k summary of safety?
Filling out a 510(k) summary of safety involves providing detailed information about the device, including its intended use, design, materials, and performance data, as well as demonstrating substantial equivalence to a predicate device.
What is the purpose of 510k summary of safety?
The purpose of the 510(k) summary of safety is to provide evidence that a new medical device is as safe and effective as an already marketed device, thereby facilitating its clearance for commercial distribution.
What information must be reported on 510k summary of safety?
The 510(k) summary must report information including the device name, a description of the device, the intended use, summaries of safety and effectiveness data, and comparisons to predicate devices.
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