21 C.F.R. § 884.6190

Current through November 30, 2024
Section 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 of this chapter, subject to the limitations in § 884.9 .

21 C.F.R. §884.6190

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