§ 862.1415. Iron-binding capacity test system.
75 words·~1 min read·
/us/cfr/t21/s§ 862.1415·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.
(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 the limitations in § 862.9. [52 FR 16122, May 1, 1987, as amended at 84 FR 71796, Dec. 30, 2019]