§ 862.2170. Micro chemistry analyzer for clinical use.
111 words·~1 min read·
/us/cfr/t21/s§ 862.2170·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A micro chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. The distinguishing characteristic of the device is that it requires only micro volume samples obtainable from pediatric patients. This device is intended for use in conjunction with certain materials to measure a variety of analytes.
(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]