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Title 21

Displaying title 21, up to date as of 7/17/2026. Title 21 was last amended 7/09/2026.
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Title 21Food and DrugsPart / Section
Chapter IFood and Drug Administration, Department of Health and Human Services1 – 1299
Subchapter HMedical Devices800 – 898
Part 862Clinical Chemistry and Clinical Toxicology Devices862.1 – 862.3970
Subpart CClinical Laboratory Instruments862.2050 – 862.2920
§ 862.2050General purpose laboratory equipment labeled or promoted for a specific medical use.
§ 862.2100Calculator/data processing module for clinical use.
§ 862.2120Continuous glucose monitor data management system.
§ 862.2140Centrifugal chemistry analyzer for clinical use.
§ 862.2150Continuous flow sequential multiple chemistry analyzer for clinical use.
§ 862.2160Discrete photometric chemistry analyzer for clinical use.
§ 862.2170Micro chemistry analyzer for clinical use.
§ 862.2230Chromatographic separation material for clinical use.
§ 862.2250Gas liquid chromatography system for clinical use.
§ 862.2260High pressure liquid chromatography system for clinical use.
§ 862.2265High throughput genomic sequence analyzer for clinical use.
§ 862.2270Thin-layer chromatography system for clinical use.
§ 862.2300Colorimeter, photometer, or spectrophotometer for clinical use.
§ 862.2310Clinical sample concentrator.
§ 862.2320Beta or gamma counter for clinical use.
§ 862.2400Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use.
§ 862.2485Electrophoresis apparatus for clinical use.
§ 862.2500Enzyme analyzer for clinical use.
§ 862.2540Flame emission photometer for clinical use.
§ 862.2560Fluorometer for clinical use.
§ 862.2570Instrumentation for clinical multiplex test systems.
§ 862.2680Microtitrator for clinical use.
§ 862.2700Nephelometer for clinical use.
§ 862.2720Plasma oncometer for clinical use.
§ 862.2730Osmometer for clinical use.
§ 862.2750Pipetting and diluting system for clinical use.
§ 862.2800Refractometer for clinical use.
§ 862.2850Atomic absorption spectrophotometer for clinical use.
§ 862.2860Mass spectrometer for clinical use.
§ 862.2900Automated urinalysis system.
§ 862.2920Plasma viscometer for clinical use.