21 CFR 862.2100 - Calculator/data processing module for clinical use.

Regulations last checked for updates: May 07, 2025

Title 21 - Food and Drugs last revised: Apr 28, 2025

View all text of Subpart C [§ 862.2050 - § 862.2920]

§ 862.2100 - Calculator/data processing module for clinical use.

(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]

authority: 21 U.S.C. 351,360,360c,360e,360j,360l,371

source: 52 FR 16122, May 1, 1987, unless otherwise noted.

cite as: 21 CFR 862.2100