21 CFR 862.2680 - Microtitrator for clinical use.

§ 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.

[ 52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000]

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United States Code