{"data":{"id":"us/21-cfr-864.8200","jurisdiction":"us","citation":"21 CFR 864.8200","heading":"Blood cell diluent.","body":"(a) Identification. A blood cell diluent is a device used to dilute blood for further testing, such as blood cell counting.\n(b) Classification. Class I (general controls). This device 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 I—Hematology Reagents"],"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":"800046530a3e007534ea68be8715760b538a69353e5e758c7bcfc9542dce08cd","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-864.8185","next":"us/21-cfr-864.8500"},"notice":"GroundRules: Original legal text. Not legal advice."}