21 C.F.R. § 884.6190 Assisted reproductive microscopes and microscope accessories.
Title 21 - Food and Drugs
(a) Identification. Assisted reproduction microscopes and microscope accessories (excluding microscope stage warmers, which are classified under assisted reproduction accessories) are optical instruments used to enlarge images of gametes or embryos. Variations of microscopes and accessories used for these purposes would include phase contrast microscopes, dissecting microscopes and inverted stage microscopes. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §884.9. [63 FR 48436, Sept. 10, 1998, as amended at 64 FR 62977, Nov. 18, 1999; 66 FR 38809, July 25, 2001]
Title 21: Food and Drugs
PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES
Subpart G—Assisted Reproduction Devices
§ 884.6190 Assisted reproductive microscopes and microscope accessories.
