[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: 21CFR862.1150]

[Page 188]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES--Table of Contents
 
               Subpart B--Clinical Chemistry Test Systems
 
Sec. 862.1150  Calibrator.

    (a) Identification. A calibrator is a device intended for medical 
purposes for use in a test system to establish points of reference that 
are used in the determination of values in the measurement of substances 
in human specimens. (See also Sec. 862.2 in this part.)
    (b) Classification. Class II.