§ 862.2680 — Microtitrator For Clinical Use

(a) Identification. A microtitrator for clinical use is a device intended for use in micronanalysis to measure the concentration of a substance by reacting it with a measure “micro” volume of a known standardized solution.

(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.