21 C.F.R. · Food and Drugs
21 C.F.R. § 866.5170

Breast milk immunological test system.

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

21 C.F.R. § 866.5170 — Breast milk immunological test system.

§ 866.5170 Breast milk immunological test system. (a) Identification. A breast milk immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the breast milk proteins. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9. [47 FR 50823, Nov. 9, 1982, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38793, July 25, 2001]

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21 C.F.R. § 866.5170
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The regulatory text of 21 C.F.R. § 866.5170 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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