[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: 21CFR864.6160]

[Page 221]
 
                        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 G--Manual Hematology Devices
 
Sec. 864.6160  Manual blood cell counting device.

    (a) Identification. A manual blood cell counting device is a device 
used to count red blood cells, white blood cells, or blood platelets.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[45 FR 60605, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989]