21 C.F.R. § 864.3400
Device for sealing microsections.
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.