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.