21 CFR § 862.2140 - Centrifugal chemistry analyzer for clinical use.

---
identifier: "/us/cfr/t21/s862.2140"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.2140 - Centrifugal chemistry analyzer for clinical use."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.2140"
section_name: "Centrifugal chemistry analyzer for clinical use."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "862"
part_name: "CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "52 FR 16122, May 1, 1987, unless otherwise noted."
cfr_part: "862"
---


# 862.2140 Centrifugal chemistry analyzer for clinical use.

(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.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]