21 C.F.R. · Food and Drugs
21 C.F.R. § 862.1020

Acid phosphatase (total or prostatic) test system.

Title 21 C.F.R. ● ACTIVE Primary Source
Regulatory Text

21 C.F.R. § 862.1020 — Acid phosphatase (total or prostatic) test system.

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

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21 C.F.R. § 862.1020
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The regulatory text of 21 C.F.R. § 862.1020 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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