[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR864.6100]

[Page 222]
 
                        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. 864.6100  Bleeding time device.


    (a) Identification. A bleeding time device is a device, usually 
employing two spring-loaded blades, that produces two small incisions in 
the patient's skin. The length of time required for the bleeding to stop 
is a measure of the effectiveness of the coagulation system, primarily 
the platelets.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 864.9.

[45 FR 60604, Sept. 12, 1980, as amended at 63 FR 59225, Nov. 3, 1998]