Antimicrobial Amikacin

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

510(k) Number

K911303 ↗

FDA Product Code

JWY

Device Class

Class II

Regulation

21 CFR Part 866.1640

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Reader

  Class I

  FDA 510(k) K926248 Active Cleared 17 May 1994

• Antimicrobial Susceptibility Test Panel

  Class II

  FDA 510(k) K930469 Active Cleared 25 Jun 1993

• Antimicrobial Ampicillin/Sulbactam

  Class II

  FDA 510(k) K911186 Active Cleared 17 Apr 1991

• Antimicrobial Suscept. Test Panel Cefonicid

  Class II

  FDA 510(k) K911559 Active Cleared 22 Apr 1991

• Antimicrobial Suscept Test Panel/Add Antibiotics

  Class II

  FDA 510(k) K904689 Active Cleared 7 Feb 1991

• Antimicrobial Suscept. Test Panel Ticarcillin

  Class II

  FDA 510(k) K911557 Active Cleared 22 Apr 1991

See all devices from Alamar Biosciences Laboratory, Inc. →

• What is the primary function of the Antimicrobial Amikacin system?

  This device is a manual antimicrobial susceptibility test system designed to determine the susceptibility of specific microorganisms to the antibiotic amikacin.

• How is this device regulated for clinical use?

  The Antimicrobial Amikacin system is classified as a class 2 medical device under regulation number 866.1640 and has received FDA 510(k) clearance, indicating it is substantially equivalent to legally marketed predicate devices.

• Who is the manufacturer of this susceptibility test system?

  This device is manufactured by Alamar Biosciences Laboratory, Inc., located in Sacramento, California.