Title 21

PART 864 SUBPART F

Subpart F - Automated and Semi-Automated Hematology Devices

• 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

21:8.0.1.1.19.6.1.1	SECTION 864.5200	864.5200 Automated cell counter.
21:8.0.1.1.19.6.1.2	SECTION 864.5220	864.5220 Automated differential cell counter.
21:8.0.1.1.19.6.1.3	SECTION 864.5240	864.5240 Automated blood cell diluting apparatus.
21:8.0.1.1.19.6.1.4	SECTION 864.5260	864.5260 Automated cell-locating device.
21:8.0.1.1.19.6.1.5	SECTION 864.5300	864.5300 Red cell indices device.
21:8.0.1.1.19.6.1.6	SECTION 864.5350	864.5350 Microsedimentation centrifuge.
21:8.0.1.1.19.6.1.7	SECTION 864.5400	864.5400 Coagulation instrument.
21:8.0.1.1.19.6.1.8	SECTION 864.5425	864.5425 Multipurpose system for in vitro coagulation studies.
21:8.0.1.1.19.6.1.9	SECTION 864.5600	864.5600 Automated hematocrit instrument.
21:8.0.1.1.19.6.1.10	SECTION 864.5620	864.5620 Automated hemoglobin system.
21:8.0.1.1.19.6.1.11	SECTION 864.5680	864.5680 Automated heparin analyzer.
21:8.0.1.1.19.6.1.12	SECTION 864.5700	864.5700 Automated platelet aggregation system.
21:8.0.1.1.19.6.1.13	SECTION 864.5800	864.5800 Automated sedimentation rate device.
21:8.0.1.1.19.6.1.14	SECTION 864.5850	864.5850 Automated slide spinner.
21:8.0.1.1.19.6.1.15	SECTION 864.5950	864.5950 Blood volume measuring device.

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