Clinical Chemistry and Clinical Toxicology Devices

United States · Last verified: 2026-09-08

Number

21 CFR 862

Type

Regulation

Issuer

U.S. FDA

Status

in_force

Authority

FDA / CDRH

What this covers

临床化学与临床毒理器械分类目录：按临床化学检验系统、临床实验室仪器、临床毒理检验系统分组，逐条给出器械定义、类别与管制要求，共 262 个条文。

Source: U.S. Food and Drug Administration (public domain)