21 CFR 866.2120
§ 866.2120 Anaerobic chamber.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 866.2120, § 866.2120 Anaerobic chamber, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89447
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Full text
(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 management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.