View all text of Subpart D [§ 864.3010 - § 864.3875]
§ 864.3800 - Automated slide stainer.
(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.