[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR866.2120]

[Page 245-246]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES--Table of Contents
 
                     Subpart C--Microbiology Devices
 
Sec. 866.2120  Anaerobic chamber.

    (a) Identification. An anaerobic chamber is a device intended for 
medical purposes to maintain an anaerobic (oxygen free) environment. It 
is used to isolate and cultivate anaerobic microorganisms.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9. The device is 
also exempt from the good manufacturing practice regulations in part 820 
of this chapter, with the exception of Sec. 820.180, with respect to 
general requirements concerning records, and

[[Page 246]]

Sec. 820.198, with respect to complaint files.

[47 FR 50823, Nov. 9, 1982, as amended at 66 FR 38790, July 25, 2001]