[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR862.1200]

[Page 199]
 
                        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. 862.1200  Corticosterone test system.

    (a) Identification. A corticosterone test system is a device 
intended to measure corticosterone (a steroid secreted by the adrenal 
gland) levels in plasma. Measurements of corticosterone are used in the 
diagnosis and treatment of adrenal disorders such as adrenal cortex 
disorders and blocks in cortisol synthesis.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]