{"data":{"id":"us/21-cfr-862.2100","jurisdiction":"us","citation":"21 CFR 862.2100","heading":"Calculator/data processing module for clinical use.","body":"(a) Identification. A calculator/data processing module for clinical use is an electronic device intended to process laboratory data.\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 § 862.9.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES","Subpart C—Clinical Laboratory Instruments"],"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":"e6d0073015e645e0ba1878a5ce494d13a63a1b41e8f96e75d1246953e9bb0109","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.2050","next":"us/21-cfr-862.2120"},"notice":"GroundRules: Original legal text. Not legal advice."}