Home
gpo.gov
govinfo.gov
e-CFR Navigation Aids
Browse
Simple Search
Advanced Search
— Boolean
— Proximity
Search History
Search Tips
Corrections
Latest Updates
User Info
FAQs
Agency List
Incorporation By Reference
Related Resources
The Code of Federal Regulations (CFR) annual edition is the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government produced by the Office of the Federal Register (OFR) and the Government Publishing Office.
Download the Code of Federal Regulations in XML.
Download the Electronic Code of Federal Regulations in XML.
Monthly Title and Part user viewing data for the e-CFR is available for download in CSV format.
Parallel Table of Authorities and Rules for the Code of Federal Regulations and the United States Code Text | PDF
Find, review, and submit comments on Federal rules that are open for comment and published in the Federal Register using Regulations.gov.
Purchase individual CFR titles from the U.S. Government Online Bookstore.
Find issues of the CFR (including issues prior to 1996) at a local Federal depository library.
[A2]
|
|
Electronic Code of Federal Regulations
e-CFR data is current as of December 5, 2019
|
Title 21: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart B—Clinical Chemistry Test Systems
§862.1075 Androstenedione test system.(a) Identification. An androstenedione test system is a device intended to measure androstenedione (a substance secreted by the testes, ovary, and adrenal glands) in serum. Adrostenedione measurements are used in the diagnosis and treatment of females with excessive levels of androgen (male sex hormone) production. (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 §862.9.
[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]
|