{"data":{"id":"us/21-cfr-864.5400","jurisdiction":"us","citation":"21 CFR 864.5400","heading":"Coagulation instrument.","body":"(a) Identification. A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.\n(b) Classification. Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 864—HEMATOLOGY AND PATHOLOGY DEVICES","Subpart F—Automated and Semi-Automated Hematology 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":"777859a965711a1d403a90058f1a0f5a7b35123d60cf424935f95bf3196fe71f","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-864.5350","next":"us/21-cfr-864.5425"},"notice":"GroundRules: Original legal text. Not legal advice."}