§862.1415. Iron-binding capacity test system.
21 C.F.R. § 862.1415
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.
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.
Notes, amendments, and revision history
Amendments
[52 FR 16122, May 1, 1987, as amended at 84 FR 71796, Dec. 30, 2019]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 52 FR 16122, May 1, 1987, unless otherwise noted.
Amendments
[52 FR 16122, May 1, 1987, as amended at 84 FR 71796, Dec. 30, 2019]