21 CFR 864.3875

§ 864.3875 Automated tissue processor.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 864.3875, § 864.3875 Automated tissue processor, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89326
Permanent ID: ys:prov:89326@1
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Full text

(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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.