[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR864.2220]

[Page 214]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 864--HEMATOLOGY AND PATHOLOGY DEVICES--Table of Contents
 
               Subpart C--Cell And Tissue Culture Products
 
Sec. 864.2220  Synthetic cell and tissue culture media and components.


    (a) Identification. Synthetic cell and tissue culture media and 
components are substances that are composed entirely of defined 
components (e.g., amino acids, vitamins, inorganic salts, etc.) that are 
essential for the survival and development of cell lines of humans and 
other animals.
    (b) Classification. Class I. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.

[45 FR 60583, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989]