21 CFR § 862.2100 Clinical Chemistry and Clinical Toxicology Devices

§ 862.2100 Calculator/data processing module for clinical use.

Current through Sep 8, 2026 · Read all of Part 862

⚠ 2 pending changes to Part 862

(a) Identification. A calculator/data processing module for clinical use is an electronic device intended to process laboratory data.

(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.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38788, July 25, 2001; 86 FR 20283, Apr. 19, 2021]

← § 862.2050 General purpose laboratory equipment labeled or promoted for a specific medical use.§ 862.2120 Continuous glucose monitor data management system. →