{"data":{"id":"us/21-cfr-892.1400","jurisdiction":"us","citation":"21 CFR 892.1400","heading":"Nuclear sealed calibration source.","body":"(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.\n(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.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 892—RADIOLOGY DEVICES","Subpart B—Diagnostic Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"b83ef495e0c1339cddadec3bfe33ef24a3ea13a172207856fe1252a17b3d2469","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-892.1390","next":"us/21-cfr-892.1410"},"notice":"GroundRules: Original legal text. Not legal advice."}