21 C.F.R. § 864.3875

Current through October 31, 2024
Section 864.3875 - Automated tissue processor
(a)Identification. An automated tissue processor is an automated system used to process tissue specimens for examination through fixation, dehydration, and infiltration.
(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. §864.3875

45 FR 60591, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 66 FR 38789 , July 25, 2001