21 CFR 864.5350

§ 864.5350 Microsedimentation centrifuge.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 864.5350, § 864.5350 Microsedimentation centrifuge, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89337
Permanent ID: ys:prov:89337@1
SHA-256: 2c2a90017ca6c861e6dcd3298995d50354403887f1417f1cda6ec25f687099da

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Full text

(a) Identification. A microsedimentation centrifuge is a device used to sediment red cells for the microsedimentation rate test. (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.