21 CFR 864.9245 - Automated blood cell separator.

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There are 2 Updates appearing in the Federal Register for 21 CFR 864. View below or at eCFR (GPOAccess)
§ 864.9245 Automated blood cell separator.
(a) Identification. An automated blood cell separator is a device that uses a centrifugal or filtration separation principle to automatically withdraw whole blood from a donor, separate the whole blood into blood components, collect one or more of the blood components, and return to the donor the remainder of the whole blood and blood components. The automated blood cell separator device is intended for routine collection of blood and blood components for transfusion or further manufacturing use.
(b) Classification. Class II (special controls). The special control for this device is a guidance for industry and FDA staff entitled “Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle.”
[72 FR 67644, Nov. 30, 2007]

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