21 CFR § 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.

[45 FR 60591, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989; 66 FR 38789, July 25, 2001]