Electronic Code of Federal Regulations
|
e-CFR data is current as of March 4, 2021 |
Title 21 → Chapter I → Subchapter H → Part 862 → Subpart C → §862.2920 |
Title 21: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart C—Clinical Laboratory Instruments
§862.2920 Plasma viscometer for clinical use.
(a) Identification. A plasma viscometer for clinical use is a device intended to measure the viscosity of plasma by determining the time period required for the plasma to flow a measured distance through a calibrated glass tube. Measurements obtained by this device are used to monitor changes in the amount of solids present in plasma in various 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 the limitations in §862.9.
[52 FR 16122, May 1, 1987, as amended at 60 FR 38900, July 28, 1995; 66 FR 38788, July 25, 2001]