[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR864.5850]

[Page 220]
 
                        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. 864.5850  Automated slide spinner.

    (a) Identification. An automated slide spinner is a device that 
prepares automatically a blood film on a microscope slide using a small 
amount of peripheral blood (blood circulating in one of the body's 
extremities, such as the arm).
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[45 FR 60603, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989]