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Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 870.1450: Densitometer.

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Where this section sits in the code
  1. Title 21—Food and Drugs
  2. CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  3. SUBCHAPTER H—MEDICAL DEVICES
  4. PART 870—CARDIOVASCULAR DEVICES
  5. Subpart B—Cardiovascular Diagnostic Devices

(a) Identification. A densitometer is a device used to measure the transmission of light through an indicator in a sample of blood.

(b) Classification. Class II (performance standards).

Collected 2026-08-27T02:24:47Z. Source file · JSON

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