21 C.F.R. § 886.1070
Anomaloscope.
Cite as 21 C.F.R. § 886.1070 (2026)
(a)
Identification.
An anomaloscope is an AC-powered device intended to test for anomalies of color vision by displaying mixed spectral lines to be matched by the patient.
(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 the limitations in § 886.9.
[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38810, July 25, 2001]
- Cross-references to the CFR
- 886.9.