21 C.F.R. § 862.1020

Current through September 30, 2024
Section 862.1020 - Acid phosphatase (total or prostatic) test system
(a)Identification. An acid phosphatase (total or prostatic) test system is a device intended to measure the activity of the acid phosphatase enzyme in plasma and serum.
(b)Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9 .

21 C.F.R. §862.1020

52 FR 16122, May 1, 1987, as amended at 84 FR 71796, Dec. 30, 2019