{"data":{"id":"us/21-cfr-864.5700","jurisdiction":"us","citation":"21 CFR 864.5700","heading":"Automated platelet aggregation system.","body":"(a) Identification. An automated platelet aggregation system is a device used to determine changes in platelet shape and platelet aggregation following the addition of an aggregating reagent to a platelet-rich plasma.\n(b) Classification. Class II (performance standards).","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":"c8b174339393c244b687e2dd28d408901cf3dbb6e313f65769a15758007dc10a","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-864.5680","next":"us/21-cfr-864.5800"},"notice":"GroundRules: Original legal text. Not legal advice."}