GroundRules
21 CFR 862.1020: Acid phosphatase (total or prostatic) test system.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
- Subpart B—Clinical Chemistry Test Systems
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON