';


Title 21 Part 892 → Subpart B → §892.1400

Title 21 → Chapter I → Subchapter H → Part 892 → Subpart B → §892.1400

Electronic Code of Federal Regulations e-CFR

Title 21 Part 892 → Subpart B → §892.1400

e-CFR data is current as of June 24, 2019

Title 21Chapter ISubchapter HPart 892Subpart B → §892.1400


Title 21: Food and Drugs
PART 892—RADIOLOGY DEVICES
Subpart B—Diagnostic Devices


§892.1400   Nuclear sealed calibration source.

(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]