Acid phosphatase (total or prostatic) test system.

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Medical Devices
  6. Clinical Chemistry and Clinical Toxicology Devices
  7. Clinical Chemistry Test Systems
  8. Acid phosphatase (total or prostatic) test system.

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§ 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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