21 CFR 862.3200 - Clinical toxicology calibrator.

§ 862.3200 Clinical toxicology calibrator.

(a)Identification. A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)

(b)Classification. Class II.

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United States Code

Title 21 published on 13-Apr-2017 03:05

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 862 after this date.

  • 2017-03-14; vol. 82 # 48 - Tuesday, March 14, 2017
    1. 82 FR 13549 - Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Continuous Glucose Monitor Secondary Display
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective March 14, 2017. The classification was applicable on January 23, 2015.
      21 CFR Part 862
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