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This document provides a 510(k) summary for the OpTmizer™ CTSTM T-Cell Expansion Serum Free Medium, detailing its intended use, classification, performance testing, and regulatory compliance information.
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How to fill out 510k summary life technologies
How to fill out 510(k) Summary Life Technologies Corporation - OpTmizerTM CTSTM T-Cell Expansion SFM
01
Gather relevant product information, including the OpTmizerTM CTSTM T-Cell Expansion SFM specifications.
02
Review the FDA guidelines for 510(k) submissions to ensure compliance.
03
Complete the Required Sections of the 510(k) form, including the device description and intended use.
04
Compile and summarize data from nonclinical studies on the OpTmizerTM CTSTM T-Cell Expansion SFM.
05
Include information on performance testing and safety standards.
06
Provide a comparison with a predicate device to demonstrate substantial equivalence.
07
Prepare the 510(k) summary document outlining the key information about the device.
08
Submit the 510(k) application electronically through the FDA's submission portal.
09
Monitor the submission status and respond to any FDA requests for additional information.
Who needs 510(k) Summary Life Technologies Corporation - OpTmizerTM CTSTM T-Cell Expansion SFM?
01
Manufacturers developing new or modified T-cell expansion media.
02
Healthcare facilities or laboratories utilizing T-cell therapies.
03
Researchers conducting studies involving T-cell expansion techniques.
04
Regulatory professionals seeking to understand the compliance landscape for T-cell expansion products.
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What is 510(k) Summary Life Technologies Corporation - OpTmizerTM CTSTM T-Cell Expansion SFM?
The 510(k) Summary for Life Technologies Corporation - OpTmizerTM CTSTM T-Cell Expansion SFM is a premarket submission made to the FDA to demonstrate that this cell culture media product is safe and effective for its intended use, which is to expand T-cells for therapeutic applications.
Who is required to file 510(k) Summary Life Technologies Corporation - OpTmizerTM CTSTM T-Cell Expansion SFM?
Any manufacturer or importer intending to market the OpTmizerTM CTSTM T-Cell Expansion SFM in the United States is required to file a 510(k) Summary with the FDA to compare their product to a legally marketed device.
How to fill out 510(k) Summary Life Technologies Corporation - OpTmizerTM CTSTM T-Cell Expansion SFM?
To fill out the 510(k) Summary for OpTmizerTM CTSTM T-Cell Expansion SFM, you must follow the FDA guidelines, including providing information on the product's intended use, description, labeling, and performance data that demonstrate safety and effectiveness.
What is the purpose of 510(k) Summary Life Technologies Corporation - OpTmizerTM CTSTM T-Cell Expansion SFM?
The purpose of the 510(k) Summary for OpTmizerTM CTSTM T-Cell Expansion SFM is to establish that this product is substantially equivalent to a predicate device, thus ensuring its safety and efficacy before marketing.
What information must be reported on 510(k) Summary Life Technologies Corporation - OpTmizerTM CTSTM T-Cell Expansion SFM?
The 510(k) Summary must report details including the device name, intended use, description of the device, comparison to predicate devices, labeling, and any supporting data for safety and effectiveness.
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