[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: 21CFR862.1210]

[Page 183]
 
                        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. 862.1210  Creatine test system.

    (a) Identification. A creatine test system is a device intended to 
measure creatine (a substance synthesized in the liver and pancreas and 
found in biological fluids) in plasma, serum, and urine. Measurements of 
creatine are used in the diagnosis and treatment of muscle diseases and 
endocrine disorders including hyperthyroidism.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]