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45 FR 12684, Feb. 26, 1980, unless otherwise noted.
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(a) Identification. A viscometer for cervical mucus is a device that is intended to measure the relative viscoelasticity of cervical mucus collected from a female patient. Measurements of relative viscoelasticity are intended for use as an adjunct in the clinical evaluation of a female with chronic infertility, to determine the time of ovulation and the penetrability of cervical mucus to motile sperm.
(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 § 884.9.
[47 FR 14706, Apr. 6, 1982, as amended at 65 FR 2320, Jan. 14, 2000]