21 CFR 862.2150
§ 862.2150 Continuous flow sequential multiple chemistry analyzer for clinical use.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 862.2150, § 862.2150 Continuous flow sequential multiple chemistry analyzer for clinical use, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89214
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.