section_subject: "Atomic absorption spectrophotometer for clinical use."
cfr_reference: "21 CFR 862.2850"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 800 to 1299"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(a)Identification. An atomic absorption spectrophotometer for clinical use is a device intended to identify and measure elements and metals (e.g., lead and mercury) in human specimens. The metal elements are identified according to the wavelength and intensity of the light that is absorbed when the specimen is converted to the atomic vapor phase. Measurements obtained by this device are used in the diagnosis and treatment of certain conditions.
(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 § 862.9.