21 CFR 864.5240
§ 864.5240 Automated blood cell diluting apparatus.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 864.5240, § 864.5240 Automated blood cell diluting apparatus, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89334
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ys:prov:89334@1- SHA-256
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Full text
(a) Identification. An automated blood cell diluting apparatus is a fully automated or semi-automated device used to make appropriate dilutions of a blood sample for further testing.
(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 § 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.