21 C.F.R. § 864.3400

Device for sealing microsections.

Last amended: 2016Year: 2026Length: 75 wordsSubsections: 1Official source

Cite as 21 C.F.R. § 864.3400 (2026)

(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]
Cross-references to the CFR
864.9.
21 C.F.R. § 864.3400: Device for sealing microsections. | Justis AI