21 CFR 862.2730
§ 862.2730 Osmometer for clinical use.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.2730, § 862.2730 Osmometer for clinical use, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89234
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Full text
(a) Identification. An osmometer for clinical use is a device intended to measure the osmotic pressure of body fluids. Osmotic pressure is the pressure required to prevent the passage of a solution with a lesser solute concentration into a solution with greater solute concentration when the two solutions are separated by a semipermeable membrane. The concentration of a solution affects its osmotic pressure, freezing point, and other physiochemical properties. Osmometers determine osmotic pressure by methods such as the measurement of the freezing point. Measurements obtained by this device are used in the diagnosis and treatment of body fluid disorders.
(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 § 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.