---
kind: "section"
citation: "21 C.F.R. § 884.6190"
title: "21"
number: "884.6190"
heading: "Assisted reproductive microscopes and microscope accessories."
url: "https://uscodex.org/cfr/21/884.6190"
---

# §884.6190. Assisted reproductive microscopes and microscope accessories.

- (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](/cfr/21/part807-subpartE.md) of this chapter, subject to the limitations in [§ 884.9](/cfr/21/884.9.md).

## Notes

### Amendments

[63 FR 48436, Sept. 10, 1998, as amended at 64 FR 62977, Nov. 18, 1999; 66 FR 38809, July 25, 2001]

### Source

Source: 63 FR 48436, Sept. 10, 1998, unless otherwise noted.

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.

### Source

Source: 45 FR 12684, Feb. 26, 1980, unless otherwise noted.

### Amendments

[63 FR 48436, Sept. 10, 1998, as amended at 64 FR 62977, Nov. 18, 1999; 66 FR 38809, July 25, 2001]