[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: 21CFR864.5400]

[Page 228]
 
                        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. 864.5400  Coagulation instrument.

    (a) Identification. A coagulation instrument is an automated or 
semiautomated device used to determine the onset of clot formation for 
in vitro coagulation studies.
    (b) Classification. Class II (performance standards).

[45 FR 60598, Sept. 12, 1980]