{"data":{"id":"us/21-cfr-864.9575","jurisdiction":"us","citation":"21 CFR 864.9575","heading":"Environmental chamber for storage of platelet concentrate.","body":"(a) Identification. An environmental chamber for storage of platelet concentrate is a device used to hold platelet-rich plasma within a preselected temperature range.\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 J—Products Used In Establishments That Manufacture Blood and Blood Products"],"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":"a8bf88d355a86c0939f41fb8dc0d7933c90f061172c76b472adc608d8cf14f19","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-864.9550","next":"us/21-cfr-864.9600"},"notice":"GroundRules: Original legal text. Not legal advice."}