21 CFR 862.2540 — Flame Emission Photometer For Clinical Use

Clinical Chemistry (CH) · Part 862 Subpart C—Clinical Laboratory Instruments · § 862.2540

Identification

A flame emission photometer for clinical use is a device intended to measure the concentration of sodium, potassium, lithium, and other metal ions in body fluids. Abnormal variations in the concentration of these substances in the body are indicative of certain disorders (e.g., electrolyte imbalance and heavy metal intoxication) and are, therefore, useful in diagnosis and treatment of those disorders.

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