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Code of Federal Regulations

Subpart C

Clinical Laboratory Instruments

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.