21 CFR 864.3400

§ 864.3400 Device for sealing microsections.

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

Cite this

Citation: 21 CFR 864.3400, § 864.3400 Device for sealing microsections, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89321
Permanent ID: ys:prov:89321@1
SHA-256: 132387342a06ba98c1501e9a70a3788a384a67c3ad31cc8e81285ea0c201b717

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Full text

(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.

Legislative history

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