1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter H - MEDICAL DEVICES
  5. Part 864 - HEMATOLOGY AND PATHOLOGY DEVICES
  6. Subpart F - Automated and Semi-Automated Hematology Devices
  7. 21 CFR § 864.5950
21 CFR § 864.5950
Blood volume measuring device
June 25, 2020
CFR

(a) Identification. A blood volume measuring device is a manual, semiautomated, or automated system that is used to calculate the red cell mass, plasma volume, and total blood volume.

(b) Classification. Class II (performance standards).

[45 FR 60603, Sept. 12, 1980]

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