21 CFR 864.5850
§ 864.5850 Automated slide spinner.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 864.5850, § 864.5850 Automated slide spinner, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89346
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Full text
(a) Identification. An automated slide spinner is a device that prepares automatically a blood film on a microscope slide using a small amount of peripheral blood (blood circulating in one of the body's extremities, such as the arm).
(b) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.