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Sensititre 18 - 24 Hour Susceptibility Plate

FDA 510(k)

Class II (US FDA 510(k))

510(k) K073653

by Trek Diagnostic Systems, Inc.

Identifiers

510(k) Number
K073653 FDA 510(k)
FDA Product Code
JWY FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.1640 FDA 510(k)
Regulation Number
866.1640 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Sensititre 18 - 24 Hour Susceptibility Plate is an in vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms. It is designed to determine the susceptibility of microorganisms to antimicrobial agents.

The device is supplied as a single-use plate and is intended for use in clinical laboratories. It is not reusable and requires proper storage conditions. The product is cleared by the FDA under 510(k) authorization.

Frequently asked questions

What is the Sensititre 18-24 Hour Susceptibility Plate used for?

This plate is an in vitro diagnostic product designed to determine the susceptibility of microorganisms to antimicrobial agents for clinical laboratories.

Is the Sensititre 18-24 Hour Susceptibility Plate reusable?

No, the device is supplied as a single-use plate and is not intended for reuse.

How should the Sensititre 18-24 Hour Susceptibility Plate be stored?

The product requires proper storage conditions to maintain its integrity, though specific storage details are not provided in the data.

What type of authorization does the Sensititre 18-24 Hour Susceptibility Plate have?

The product is cleared by the FDA under a 510(k) authorization.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SENSITITRE 18 - 24 HOURS SUSCEPTIBILITY PLATES by TREK DIAGNOSTIC ..., SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATE (K073653) — FDA 510 (k ..., K031545 - Sensititre 18-24 Hour Susceptibility Plate, Sensititre 18-24 Hours Susceptibility Plates (Quinupristin/Dalfopristin ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Trek Diagnostic Systems, Inc.

Sources (1)

  • FDA 510(k) K073653 24 fields · synced Sep 25, 2026