CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES > SUBPART C—Clinical Laboratory Instruments (§862.2050 to §862.2920) > 862.2300—Colorimeter, photometer, or spectrophotometer for clinical use.

862.2300—Colorimeter, photometer, or spectrophotometer for clinical use.

(a) Identification. A colorimeter, a photometer, or a spectrophotometer for clinical use is an instrument intended to measure radiant energy emitted, transmitted, absorbed, or reflected under controlled conditions. The device may include a monochromator to produce light of a specific wavelength.
(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 § 862.9.

Code of Federal Regulations

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000]