{"data":{"id":"us/21-cfr-864.6100","jurisdiction":"us","citation":"21 CFR 864.6100","heading":"Bleeding time device.","body":"(a) Identification. A bleeding time device is a device, usually employing two spring-loaded blades, that produces two small incisions in the patient's skin. The length of time required for the bleeding to stop is a measure of the effectiveness of the coagulation system, primarily the platelets.\n(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 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 G—Manual 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":"abfc221bc17818282ad547a604d448fd10f2fe5d4de82bc7cf64f1172d8ea650","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-864.5950","next":"us/21-cfr-864.6150"},"notice":"GroundRules: Original legal text. Not legal advice."}