Hardydisk Mezlocillin 75mcg

FDA 510(k)

Class II (US FDA 510(k))

510(k) K994212

Identifiers

510(k) Number: K994212 FDA 510(k)
FDA Product Code: JTN FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 866.1620 FDA 510(k)
Regulation Number: 866.1620 FDA 510(k)
Advisory Committee: Microbiology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The HardyDisk Mezlocillin 75mcg is an antimicrobial susceptibility test disk used in clinical microbiology laboratories to determine bacterial resistance to the antibiotic mezlocillin. The device consists of a paper disk impregnated with a specific concentration of mezlocillin, designed for use in susceptibility testing protocols.

The HardyDisk Mezlocillin 75mcg is supplied as a spring-loaded cartridge containing 50 disks, compatible with BBL single or multiple disk dispensers. It is intended for single-use in laboratory settings and is not reusable. The device is regulated under FDA 510(k) clearance (K994212) and is classified as a Class II device with special controls.

Frequently asked questions

What is the HardyDisk Mezlocillin 75mcg used for?

It is an antimicrobial susceptibility test disk used in clinical microbiology laboratories to determine bacterial resistance to the antibiotic mezlocillin.

How is the HardyDisk Mezlocillin 75mcg supplied?

It is supplied as a spring-loaded cartridge containing 50 disks, which is compatible with BBL single or multiple disk dispensers.

Is the HardyDisk Mezlocillin 75mcg intended for single use?

Yes, the device is intended for single-use in laboratory settings and is not reusable.

What is the regulatory status of the HardyDisk Mezlocillin 75mcg?

The device is regulated under FDA 510(k) clearance (K994212) and is classified as a Class II device with special controls.

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: HARDYDISK MEZLOCILLIN 75MCG (K994212) — FDA 510(k) | Innolitics, HardyDisks™ for Antibiotic Resistance/Antibiotic ... - Hardy Diagnostics, K994212 - HARDYDISK MEZLOCILLIN 75MCG | FDA 510 (k), Susceptibility Testing - Clinical Diagnostics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K994212	Class II	Active

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Manufacturer

Manufacturer: Hardy Diagnostics

Sources (1)

FDA 510(k) K994212 24 fields · synced Sep 26, 2026