21 C.F.R. § 864.3400

Current through November 30, 2024
Section 864.3400 - Device for sealing microsections
(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 .

21 C.F.R. §864.3400

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