21 CFR 862.1415
§ 862.1415 Iron-binding capacity test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1415, § 862.1415 Iron-binding capacity test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89127
- Permanent ID
ys:prov:89127@1- SHA-256
1ae94df0ceec726941622c7332a505de2b83eb93b31cefc2a9d57db8ce5c044c
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.