(a) Identification. A lead test system is a device intended to measure lead, a heavy metal, in blood and urine. Measurements obtained by this device are used in the diagnosis and treatment of lead poisoning.
(b) Classification. Class II.
21 CFR Part 862 · Clinical Chemistry and Clinical Toxicology Devices
§ 862.3550 Lead test system
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.
Amendment history
Federal Register documents that created or amended this section.
- 52 FR 16122 1 May 1987