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Ticarcillin 75MCG Sensitivity Discs

by Difco Laboratories, Inc.

510(k) K833415

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK833415 Date11 Jan 1984ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JTN
Device Class
Class II
Regulation
21 CFR Part 866.1620
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Ticarcillin 75mcg Sensitivity Discs are antimicrobial susceptibility test discs used to determine the susceptibility of microorganisms. These discs are designed for use in manual antimicrobial susceptibility testing methods.

This device is supplied by Difco Laboratories, Inc. and has received FDA 510(k) clearance. It is classified under regulation number 866.1620 for use in microbiology laboratory settings.

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Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of Ticarcillin 75mcg Sensitivity Discs?

    These discs are used in microbiology laboratory settings to determine the susceptibility of microorganisms to the antimicrobial agent ticarcillin. They are specifically designed for use in manual antimicrobial susceptibility testing methods.

  • What is the regulatory status of this device?

    Ticarcillin 75mcg Sensitivity Discs have received FDA 510(k) clearance. The device is classified under regulation number 866.1620, which pertains to antimicrobial susceptibility test discs used in microbiology.

  • Who is the manufacturer of these sensitivity discs?

    The discs are supplied by Difco Laboratories, Inc., located in McHenry, Illinois. The product was cleared for use under the 510(k) process with the K-number K833415.