Medical Devices; Exemption From Premarket Notification; Class II Devices; Triiodothyronine Test System
Information
Type
Rule
Regulated products
Medical Devices
Published
October 18, 2000
Last updated
October 18, 2000
Description
Document number 00-26740. The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for the triiodothyronine test system with certain limitations. This rule will exempt from premarket notification the triiodothyronine test system intended for measuring the hormone triiodothyronine in serum and plasma. FDA is publishing this order in accordance with procedures established by the Food and Drug Administration Modernization Action of 1997 (FDAMA).
Tags
Organization
Country / Region
United States
License
Other (Public Domain)