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Hardydisk Cefamandole, 30MCG

FDA 510(k)

Class II (US FDA 510(k))

510(k) K000022

by Hardy Diagnostics

Identifiers

510(k) Number
K000022 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 Cefamandole, 30MCG is an antimicrobial susceptibility test disc used for Kirby-Bauer disk diffusion testing. It is designed to determine bacterial susceptibility to cefamandole, a cephalosporin antibiotic, by measuring the zone of inhibition around the disc on inoculated agar plates.

This single-use, non-sterile disc is intended for use in microbiology laboratories. Supplied in cartridges of 50 discs, it adheres to FDA 510(k) clearance (K000022) under regulation 866.1620 for susceptibility testing. Storage conditions and expiration dates are specified on the packaging, and it is classified as a Class II medical device.

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 CEFAMANDOLE, 30MCG (K000022) - FDA 510(k), HardyDisks™ for Antibiotic Resistance/Antibiotic ... - Hardy Diagnostics, HardyDisk™ AST Cefiderocol, FDC30 - Hardy Diagnostics, HARDYDISK CEFAMANDOLE, 30MCG 510(k) K000022 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hardy Diagnostics

Sources (1)

  • FDA 510(k) K000022 24 fields · synced Sep 19, 2026