21 CFR 862.2320 - Beta or gamma counter for clinical use.

§ 862.2320 Beta or gamma counter for clinical use.
(a) Identification. A beta or gamma counter for clinical use is a device intended to detect and count beta or gamma radiation emitted by clinical samples. Clinical samples are prepared by addition of a radioactive reagent to the sample. These measurements are useful in the diagnosis and treatment of various disorders.
(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 § 862.9.
[52 FR 16122, May 1, 1987, as amended at 60 FR 38900, July 28, 1995; 66 FR 38788, July 25, 2001]

Title 21 published on 2013-04-01

no entries appear in the Federal Register after this date.

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