21 CFR 862.2100

§ 862.2100 Calculator/data processing module for clinical use.

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

Cite this

Citation: 21 CFR 862.2100, § 862.2100 Calculator/data processing module for clinical use, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89211
Permanent ID: ys:prov:89211@1
SHA-256: 1fc218262e5921c1befbc19e22a22d43113123d0c37a088d47545bef2c81bfef

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Full text

(a) Identification. A calculator/data processing module for clinical use is an electronic device intended to process laboratory data. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Legislative history

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