21 CFR Subpart C
Clinical Laboratory Instruments
June 25, 2020
§
862.2050
General purpose laboratory equipment labeled or promoted for a specific medical use
§
862.2100
Calculator/data processing module for clinical use
§
862.2120
Continuous glucose monitor data management system
§
862.2140
Centrifugal chemistry analyzer for clinical use
§
862.2150
Continuous flow sequential multiple chemistry analyzer for clinical use
§
862.2160
Discrete photometric chemistry analyzer for clinical use
§
862.2170
Micro chemistry analyzer for clinical use
§
862.2230
Chromatographic separation material for clinical use
§
862.2250
Gas liquid chromatography system for clinical use
§
862.2260
High pressure liquid chromatography system for clinical use
§
862.2265
High throughput genomic sequence analyzer for clinical use
§
862.2270
Thin-layer chromatography system for clinical use
§
862.2300
Colorimeter, photometer, or spectrophotometer for clinical use
§
862.2310
Clinical sample concentrator
§
862.2320
Beta or gamma counter for clinical use
§
862.2400
Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use
§
862.2485
Electrophoresis apparatus for clinical use
§
862.2500
Enzyme analyzer for clinical use
§
862.2540
Flame emission photometer for clinical use
§
862.2560
Fluorometer for clinical use
§
862.2570
Instrumentation for clinical multiplex test systems
§
862.2680
Microtitrator for clinical use
§
862.2700
Nephelometer for clinical use
§
862.2720
Plasma oncometer for clinical use
§
862.2730
Osmometer for clinical use
§
862.2750
Pipetting and diluting system for clinical use
§
862.2800
Refractometer for clinical use
§
862.2850
Atomic absorption spectrophotometer for clinical use
§
862.2860
Mass spectrometer for clinical use
§
862.2900
Automated urinalysis system
§
862.2920
Plasma viscometer for clinical use
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