FDA CDRH 510(k) Automated Analyzers

“Data of Commercialization of Original Equipment Manufacturer, Secondary and Generic Reagents for Automated Analyzers”

This document was issued June 10, 1996 and there is a paragraph discussing subsequent models of the same system that don’t require a new 510(k) in terms of automated analyzers and their reagents. It mentions that scientifically valid studies should include documentation and validation testing for software modifications. A letter to FDA describing the changes after completion of the testing may be sent in place of a 510(k) and FDA will add this letter to the 510(k) file.

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