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 .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