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Code of Federal Regulations (Last Updated: October 10, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 866 - Immunology and Microbiology Devices |
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Subpart A - General Provisions |
| § 866.1 - Scope. |
| § 866.3 - Effective dates of requirement for premarket approval. |
| § 866.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). |