Code of Federal Regulations · Section

§ 862.2100 — Calculator/data Processing Module For Clinical Use

21 C.F.R. § 862.2100

View:

(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. § 862.2050 21 C.F.R. § 862.2120

Authorizing Statute