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53 FR 1567, Jan. 20, 1988, unless otherwise noted.
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Subscribe to: 21 CFR 892.1400
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Nomenclature changes to part 892 appear at 73 FR 35341, June 23, 2008.
(a) Identification. A nuclear sealed calibration source is a device that consists of an encapsulated reference radionuclide intended for calibration of medical nuclear radiation detectors.
(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 § 892.9.
[53 FR 1567, Jan. 20, 1988, as amended at 54 FR 13832, Apr. 5, 1989; 66 FR 38819, July 25, 2001]