StacksVerified U.S. regulatory reference

21 CFR §862.2140

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (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.
  2. (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.