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Next Subject 		classification of cell culture mediapebsicola2008-04-14Click here to register.
How are cell culture media classificated and on which level?
Medical devices?


 
Re: classification of cell culture media
lubrol2008-04-14Click here to register.
Cell Culture Media and devices (e.g. flasks, dishes, plates) are considered to be Class I medical devices in the United States. These are 510K exempt from FDA submissions in most cases. The exact requirements can be found on the FDA CDER website at: http://tinyurl.com/q2mh2
Search on "cell culture"
There are exceptions to the exemption such as media used for ex vivo or in vitro fertilization. These are regulated differently - requiring a 510K submission.

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