Automated and Semi-Automated Hematology Devices

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Medical Devices
  6. Hematology and Pathology Devices
  7. Automated and Semi-Automated Hematology Devices

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Section
864.5200

Automated cell counter.

Section
864.5220

Automated differential cell counter.

Section
864.5240

Automated blood cell diluting apparatus.

Section
864.5260

Automated cell-locating device.

Section
864.5300

Red cell indices device.

Section
864.5350

Microsedimentation centrifuge.

Section
864.5400

Coagulation instrument.

Section
864.5425

Multipurpose system for in vitro coagulation studies.

Section
864.5600

Automated hematocrit instrument.

Section
864.5620

Automated hemoglobin system.

Section
864.5680

Automated heparin analyzer.

Section
864.5700

Automated platelet aggregation system.

Section
864.5800

Automated sedimentation rate device.

Section
864.5850

Automated slide spinner.

Section
864.5950

Blood volume measuring device.