Product code

DJL: Free radical assay, amphetamine

FDA product code · Class II · Toxicology

Key facts

Product code DJL
Device Free radical assay, amphetamine
Device class Class II
Regulation number 862.3100
Review panel Toxicology
Medical specialty Toxicology
Submission type 510(k)
GMP exempt No
Implanted device No
Life-sustaining or life-supporting No

At a glance

  • None 510(k) clearances
  • None De Novo grants
  • None PMA approvals
  • None HDE approvals
  • None UDI devices (GUDID)
  • None MAUDE adverse event reports
  • None Recalled products (Z-numbers)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device product codes

FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.

Source: U.S. Food and Drug Administration (FDA), Product Classification database

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