[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: 21CFR864.6600]

[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. 864.6600  Osmotic fragility test.

    (a) Identification. An osmotic fragility test is a device used to 
determine the resistance of red blood cells to hemolysis (destruction) 
in varying concentrations of hypotonic saline solutions.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[45 FR 60607, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989]