StacksVerified U.S. regulatory reference

21 CFR §862.2100

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Identification. A calculator/data processing module for clinical use is an electronic device intended to process laboratory data.
  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 the limitations in § 862.9.