[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR864.6675]

[Page 230]
 
                        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. 864.6675  Platelet aggregometer.

    (a) Identification. A platelet aggregometer is a device, used to 
determine changes in platelet shape and platelet aggregation following 
the addition of an aggregating reagent to a platelet rich plasma.
    (b) Classification. Class II (performance standards).

[45 FR 60608, Sept. 12, 1980]