21 C.F.R. § 862.2320 Beta or gamma counter for clinical use.
Title 21 - Food and Drugs
(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: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart C—Clinical Laboratory Instruments
§ 862.2320 Beta or gamma counter for clinical use.
