21 CFR 862.2150 — Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use

Clinical Chemistry (CH) · Part 862 Subpart C—Clinical Laboratory Instruments · § 862.2150

Identification

A continuous flow sequential multiple chemistry analyzer for clinical use is a modular analytical instrument intended to simultaneously perform multiple chemical procedures using the principles of automated continuous flow systems. This device is intended for use in conjunction with certain materials to measure a variety of analytes.

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