21 CFR 862.2140
§ 862.2140 Centrifugal chemistry analyzer for clinical use.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.2140, § 862.2140 Centrifugal chemistry analyzer for clinical use, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89213
- Permanent ID
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Full text
(a) Identification. A centrifugal chemistry analyzer for clinical use is an automatic device intended to centrifugally mix a sample and a reagent and spectrophotometrically measure concentrations of the sample constituents. This device is intended for use in conjunction with certain materials to measure a variety of analytes.
(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 § 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.