Title 21: Food and Drugs
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/ PART 862 - CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
/ Subpart C - Clinical Laboratory Instruments / § 862.2100 Calculator/data processing module for clinical use.
§ 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 store, retrieve, and 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.