21 CFR 864.9185 - Blood grouping view box.

§ 864.9185 Blood grouping view box.

(a)Identification. A blood grouping view box is a device with a glass or plastic viewing surface, which may be illuminated and heated, that is used to view cell reactions in antigen-antibody testing.

(b)Classification. Class I (general 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 60641, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]

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United States Code

Title 21 published on 2015-12-03

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

  • 2016-03-01; vol. 81 # 40 - Tuesday, March 1, 2016
    1. 81 FR 10553 - Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Proposed rule.
      Submit either electronic or written comments by May 31, 2016. Please see section IV of this document for the proposed effective date of a final rule that may issue based on this proposal.
      21 CFR Part 864

Title 21 published on 2015-12-03.

No entries appear in the Federal Register after this date, for 21 CFR Part 864.