21 C.F.R. § 862.2100

Current through November 30, 2024
Section 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 .

21 C.F.R. §862.2100

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
86 FR 20283 , 4/19/2021