21 CFR § 864.3400 Hematology and Pathology Devices

§ 864.3400 Device for sealing microsections.

Current through Sep 8, 2026 · Read all of Part 864

(a) Identification. A device for sealing microsections is an automated instrument used to seal stained cells and microsections for histological and cytological examination.

(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 60589, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989; 66 FR 38789, July 25, 2001]

← § 864.3300 Cytocentrifuge.§ 864.3600 Microscopes and accessories. →