GroundRules
21 CFR 864.3800: Automated slide stainer.
Where this section sits in the code
- 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
(a) Identification. An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagnosis.
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON