21 CFR 862.3645 - Neuroleptic drugs radioreceptor assay test system.

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There are 2 Updates appearing in the Federal Register for 21 CFR 862. View below or at eCFR (GPOAccess)
§ 862.3645 Neuroleptic drugs radioreceptor assay test system.
(a) Identification. A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.
(b) Classification. Class II.

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.

  • 2014-08-25; vol. 79 # 164 - Monday, August 25, 2014
    1. 79 FR 50549 - Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of Hemoglobin A1c Test System
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective September 24, 2014. The classification was applicable May 23, 2013.
      21 CFR Part 862

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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 862 after this date.

  • 2014-08-25; vol. 79 # 164 - Monday, August 25, 2014
    1. 79 FR 50549 - Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of Hemoglobin A1c Test System
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective September 24, 2014. The classification was applicable May 23, 2013.
      21 CFR Part 862