Precept Ticarcillin/Clavulanic Acid

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

Full name

Precept (Tm) Ticarcillin/Clavulanic Acid

510(k) Number

K864069 ↗

FDA Product Code

JWY

Device Class

Class II

Regulation

21 CFR Part 866.1640

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Rim Spot Indole

  Class I

  FDA 510(k) K842097 Active Cleared 7 Jun 1984

• Rim-Haemophilus 2

  Class I

  FDA 510(k) K832239 Active Cleared 12 Aug 1983

• Rim - Nitrate Test

  Class I

  FDA 510(k) K841270 Active Cleared 20 Apr 1984

• Rim-Bile Esculin Test

  Class I

  FDA 510(k) K841262 Active Cleared 20 Apr 1984

• Austin Enteric System

  Class I

  FDA 510(k) K860194 Active Cleared 20 Feb 1986

• Precept Avgmentin

  Class II

  FDA 510(k) K853263 Active Cleared 29 Aug 1985

See all devices from Austin Biological Laboratories →

• What is the primary function of the Precept Ticarcillin/Clavulanic Acid system?

  This device is a manual antimicrobial susceptibility test system. It is specifically designed to determine the susceptibility of microorganisms when exposed to the antibiotic combination of ticarcillin and clavulanic acid.

• What is the regulatory classification of this device?

  The Precept Ticarcillin/Clavulanic Acid system is classified as a Class 2 medical device under regulation number 866.1640. It received FDA 510(k) clearance on November 13, 1986, under submission number K864069.

• Who is the manufacturer of this susceptibility test system?

  The device is manufactured by Austin Biological Laboratories, located in Austin, Texas. The system is categorized under the microbiology medical specialty.