{"data":{"id":"us/21-cfr-864.3800","jurisdiction":"us","citation":"21 CFR 864.3800","heading":"Automated slide stainer.","body":"(a) Identification. An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagnosis.\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 D—Pathology Instrumentation and Accessories"],"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":"4fb00bfad37c4d3bae330b2df2fc85171ec9545476bc8e33776a6f243f98875a","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-864.3750","next":"us/21-cfr-864.3875"},"notice":"GroundRules: Original legal text. Not legal advice."}