21 C.F.R. § 862.1415

Current through September 30, 2024
Section 862.1415 - Iron-binding capacity test system
(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 .

21 C.F.R. §862.1415

52 FR 16122, May 1, 1987, as amended at 84 FR 71796, Dec. 30, 2019