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Electronic Code of Federal Regulations

e-CFR data is current as of October 16, 2019

Title 21Chapter ISubchapter HPart 866Subpart C → §866.2120


Title 21: Food and Drugs
PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart C—Microbiology Devices


§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 §866.9. The device is also exempt from the good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of §820.180, with respect to general requirements concerning records, and §820.198, with respect to complaint files.

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

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