21 CFR 862.2850 — Atomic Absorption Spectrophotometer, General Use

Clinical Chemistry (CH) · Part 862 Subpart C—Clinical Laboratory Instruments · § 862.2850

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.

Classification Rationale

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.

Product Codes