Amikacin

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K780494 ↗

FDA Product Code

KLQ

Device Class

Class II

Regulation

21 CFR Part 862.3035

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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See all devices from Diagnostic Products Corp. →

• What is the primary purpose of the Amikacin radioimmunoassay?

  This device is designed for use in clinical toxicology to measure the concentration of amikacin within clinical samples, providing quantitative data for diagnostic assessment.

• How is this device classified for regulatory purposes?

  The Amikacin radioimmunoassay is categorized as a Class 2 medical device and is regulated under FDA 510(k) clearance K780494, which indicates it has been found substantially equivalent to legally marketed predicate devices.

• Who is the manufacturer of this radioimmunoassay device?

  This device is manufactured by Diagnostic Products Corp., located in McHenry, Illinois, and is identified by the product code KLQ within the clinical toxicology medical specialty.