21 CFR Subpart F
Automated and Semi-Automated Hematology Devices
June 25, 2020
§
864.5300
Red cell indices device
§
864.5200
Automated cell counter
§
864.5220
Automated differential cell counter
§
864.5240
Automated blood cell diluting apparatus
§
864.5260
Automated cell-locating device
§
864.5350
Microsedimentation centrifuge
§
864.5400
Coagulation instrument
§
864.5425
Multipurpose system for in vitro coagulation studies
§
864.5600
Automated hematocrit instrument
§
864.5620
Automated hemoglobin system
§
864.5680
Automated heparin analyzer
§
864.5700
Automated platelet aggregation system
§
864.5800
Automated sedimentation rate device
§
864.5850
Automated slide spinner
§
864.5950
Blood volume measuring device
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