21 C.F.R. · Food and Drugs
21 C.F.R. § 866.2580

Gas-generating device.

Title 21 C.F.R. ● ACTIVE Primary Source
Regulatory Text

21 C.F.R. § 866.2580 — Gas-generating device.

§ 866.2580 Gas-generating device. (a) Identification. A gas-generating device is a device intended for medical purposes that produces predetermined amounts of selected gases to be used in a closed chamber in order to establish suitable atmospheric conditions for cultivation of microorganisms with special atmospheric requirements. The device aids in the diagnosis of disease. (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. [47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989; 66 FR 38791, July 25, 2001]

Source: ecfr.gov · govinfo.gov — public domain Official Source ↗
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21 C.F.R. § 866.2580
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The regulatory text of 21 C.F.R. § 866.2580 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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