READAR

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

510(k) Number

K930478 ↗

FDA Product Code

LRG

Device Class

Class II

Regulation

21 CFR Part 866.1640

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Readar/Susceptibility, Gram Negative Panels

  Class II

  FDA 510(k) K925859 Active Cleared 8 Jul 1993

• Antimicrobial Susceptibility Test Panel Modification

  Class II

  FDA 510(k) K944723 Active Cleared 21 Oct 1994

• Microdilution Device for Determining Gentamicin & Strrptomycin for Detection of High Level Aminoglycoside Resistance

  Class II

  FDA 510(k) K943756 Active Cleared 17 Feb 1995

• Alamar Biosciences Laboratory, Inc. Antimicrobial Susceptibility Test Panel

  Class II

  FDA 510(k) K933885 Active Cleared 16 Nov 1993

• What is the READAR device used for?

  The READAR is an instrument designed to automate the reading and interpretation of overnight susceptibility systems used in microbiology laboratories, streamlining the process of analyzing test results.

• How is the READAR supplied and what is its regulatory status?

  The READAR is supplied by Alamar Biosciences, Inc. and is FDA 510(k) cleared with product code LRG, classified as a Class II device for automated interpretation of overnight susceptibility systems in microbiology settings.

• Is the READAR a single-use or reusable device?

  The device information does not specify whether the READAR is single-use or reusable, as this detail is not included in the provided device data.

• What sizes or models of the READAR are available?

  The device data does not mention different sizes or models of the READAR, indicating that only one version of this instrument is currently available from the manufacturer.