Title 21

PART 862 SUBPART C

Subpart C - Clinical Laboratory Instruments

• 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
• 52 FR 16122, May 1, 1987, unless otherwise noted.

21:8.0.1.1.18.3.1.1	SECTION 862.2050	862.2050 General purpose laboratory equipment labeled or promoted for a specific medical use.
21:8.0.1.1.18.3.1.2	SECTION 862.2100	862.2100 Calculator/data processing module for clinical use.
21:8.0.1.1.18.3.1.3	SECTION 862.2120	862.2120 Continuous glucose monitor data management system.
21:8.0.1.1.18.3.1.4	SECTION 862.2140	862.2140 Centrifugal chemistry analyzer for clinical use.
21:8.0.1.1.18.3.1.5	SECTION 862.2150	862.2150 Continuous flow sequential multiple chemistry analyzer for clinical use.
21:8.0.1.1.18.3.1.6	SECTION 862.2160	862.2160 Discrete photometric chemistry analyzer for clinical use.
21:8.0.1.1.18.3.1.7	SECTION 862.2170	862.2170 Micro chemistry analyzer for clinical use.
21:8.0.1.1.18.3.1.8	SECTION 862.2230	862.2230 Chromatographic separation material for clinical use.
21:8.0.1.1.18.3.1.9	SECTION 862.2250	862.2250 Gas liquid chromatography system for clinical use.
21:8.0.1.1.18.3.1.10	SECTION 862.2260	862.2260 High pressure liquid chromatography system for clinical use.
21:8.0.1.1.18.3.1.11	SECTION 862.2265	862.2265 High throughput genomic sequence analyzer for clinical use.
21:8.0.1.1.18.3.1.12	SECTION 862.2270	862.2270 Thin-layer chromatography system for clinical use.
21:8.0.1.1.18.3.1.13	SECTION 862.2300	862.2300 Colorimeter, photometer, or spectrophotometer for clinical use.
21:8.0.1.1.18.3.1.14	SECTION 862.2310	862.2310 Clinical sample concentrator.
21:8.0.1.1.18.3.1.15	SECTION 862.2320	862.2320 Beta or gamma counter for clinical use.
21:8.0.1.1.18.3.1.16	SECTION 862.2400	862.2400 Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use.
21:8.0.1.1.18.3.1.17	SECTION 862.2485	862.2485 Electrophoresis apparatus for clinical use.
21:8.0.1.1.18.3.1.18	SECTION 862.2500	862.2500 Enzyme analyzer for clinical use.
21:8.0.1.1.18.3.1.19	SECTION 862.2540	862.2540 Flame emission photometer for clinical use.
21:8.0.1.1.18.3.1.20	SECTION 862.2560	862.2560 Fluorometer for clinical use.
21:8.0.1.1.18.3.1.21	SECTION 862.2570	862.2570 Instrumentation for clinical multiplex test systems.
21:8.0.1.1.18.3.1.22	SECTION 862.2680	862.2680 Microtitrator for clinical use.
21:8.0.1.1.18.3.1.23	SECTION 862.2700	862.2700 Nephelometer for clinical use.
21:8.0.1.1.18.3.1.24	SECTION 862.2720	862.2720 Plasma oncometer for clinical use.
21:8.0.1.1.18.3.1.25	SECTION 862.2730	862.2730 Osmometer for clinical use.
21:8.0.1.1.18.3.1.26	SECTION 862.2750	862.2750 Pipetting and diluting system for clinical use.
21:8.0.1.1.18.3.1.27	SECTION 862.2800	862.2800 Refractometer for clinical use.
21:8.0.1.1.18.3.1.28	SECTION 862.2850	862.2850 Atomic absorption spectrophotometer for clinical use.
21:8.0.1.1.18.3.1.29	SECTION 862.2860	862.2860 Mass spectrometer for clinical use.
21:8.0.1.1.18.3.1.30	SECTION 862.2900	862.2900 Automated urinalysis system.
21:8.0.1.1.18.3.1.31	SECTION 862.2920	862.2920 Plasma viscometer for clinical use.

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