Readar

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

510(k) Number

K925951 ↗

FDA Product Code

LRG

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 Readar instrument?

  The Readar is designed to automate the reading and interpretation of overnight susceptibility systems. It serves as a laboratory tool to assist in the analysis of microbiology samples.

• What is the regulatory status of the Readar?

  The Readar is classified as a Class 2 medical device under regulation number 866.1640. It has received FDA 510(k) clearance, which is identified by k-number K925951.

• Which medical specialty is this device intended for?

  The Readar is categorized under the microbiology specialty. It is specifically designed to support laboratory workflows related to the analysis of susceptibility systems.