21 CFR 864.6400 - Hematocrit measuring device.

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There are 2 Updates appearing in the Federal Register for 21 CFR 864. View below or at eCFR (GPOAccess)
§ 864.6400 Hematocrit measuring device.
(a) Identification. A hematocrit measuring device is a system consisting of instruments, tubes, racks, and a sealer and a holder. The device is used to measure the packed red cell volume in blood to determine whether the patient's total red cell volume is normal or abnormal. Abnormal states include anemia (an abnormally low total red cell volume) and erythrocytosis (an abnormally high total red cell mass). The packed red cell volume is produced by centrifuging a given volume of blood.
(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.
[45 FR 60606, Sept. 12, 1980, as amended at 63 FR 59225, Nov. 3, 1998]

Title 21 published on 2014-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-09-03; vol. 79 # 170 - Wednesday, September 3, 2014
    1. 79 FR 52195 - Medical Devices; Hematology and Pathology Devices; Classification of Early Growth Response 1 Gene Fluorescence In-Situ Hybridization Test System for Specimen Characterization
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective October 3, 2014. The classification was applicable July 29, 2013.
      21 CFR Part 864

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United States Code

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 864 after this date.

  • 2014-09-03; vol. 79 # 170 - Wednesday, September 3, 2014
    1. 79 FR 52195 - Medical Devices; Hematology and Pathology Devices; Classification of Early Growth Response 1 Gene Fluorescence In-Situ Hybridization Test System for Specimen Characterization
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective October 3, 2014. The classification was applicable July 29, 2013.
      21 CFR Part 864