21 CFR 862.1020
§ 862.1020 Acid phosphatase (total or prostatic) test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1020, § 862.1020 Acid phosphatase (total or prostatic) test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89037
- Permanent ID
ys:prov:89037@1- SHA-256
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.