[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR864.5950]

[Page 245]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 864_HEMATOLOGY AND PATHOLOGY DEVICES--Table of Contents
 
        Subpart F_Automated and Semi-Automated Hematology Devices
 
Sec. 864.5950  Blood volume measuring device.

    (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]