---
kind: "section"
citation: "21 C.F.R. § 864.5620"
title: "21"
number: "864.5620"
heading: "Automated hemoglobin system."
url: "https://uscodex.org/cfr/21/864.5620"
---

# §864.5620. Automated hemoglobin system.

- (a) **Identification.** An automated hemoglobin system is a fully automated or semi-automated device which may or may not be part of a larger system. The generic type of device consists of the reagents, calibrators, controls, and instrumentation used to determine the hemoglobin content of human blood.
- (b) **Classification.** Class II (performance standards).

## Notes

### Amendments

[45 FR 60601, Sept. 12, 1980]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Amendments

[45 FR 60601, Sept. 12, 1980]