General Provisions

  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. General Provisions

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Section
862.1

Scope.

Section
862.2

Regulation of calibrators.

Section
862.3

Effective dates of requirement for premarket approval.

Section
862.9

Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).