21 CFR § 862.1020 Clinical Chemistry and Clinical Toxicology Devices

§ 862.1020 Acid phosphatase (total or prostatic) test system.

Current through Sep 8, 2026 · Read all of Part 862

⚠ 2 pending changes to Part 862

(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.

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

← § 862.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).§ 862.1025 Adrenocorticotropic hormone (ACTH) test system. →