21 CFR § 862.2150 - Continuous flow sequential multiple chemistry analyzer for clinical use.

---
identifier: "/us/cfr/t21/s862.2150"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.2150 - Continuous flow sequential multiple chemistry analyzer for clinical use."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.2150"
section_name: "Continuous flow sequential multiple 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"
---


# 862.2150 Continuous flow sequential multiple chemistry analyzer for clinical use.

(a) *Identification.* A continuous flow sequential multiple chemistry analyzer for clinical use is a modular analytical instrument intended to simultaneously perform multiple chemical procedures using the principles of automated continuous flow systems. 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]