[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR884.1040]

[Page 420]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES--Table of Contents
 
       Subpart B--Obstetrical and Gynecological Diagnostic Devices
 
Sec. 884.1040  Viscometer for cervical mucus.


    (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 Sec. 884.9.

[47 FR 14706, Apr. 6, 1982, as amended at 65 FR 2320, Jan. 14, 2000]