§ 862.1150. Calibrator.
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/us/cfr/t21/s§ 862.1150·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A 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. (See also § 862.2 in this part.)
(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 the limitations in § 862.9. [52 FR 16122, May 1, 1987, as amended at 84 FR 71796, Dec. 30, 2019]