TIGECYCLINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC— 510(k) K060286

Name: FDA 510(k) clearance K060286
Creator: U.S. Food and Drug Administration
Published: 2006-03-17

Substantially Equivalent

Oxoid , Ltd.

FDA 510(k) clearance K060286 for TIGECYCLINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC, Substantially Equivalent on 2006-03-17. Applicant: Oxoid , Ltd.. Device class: 2.

Clearance details

Applicant: Oxoid , Ltd.
Product code: Code JTN
Device class: Class 2
Regulation: 21 CFR 866.1620
Advisory panel: Microbiology
Date received: 2006-02-03
Decision date: 2006-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Basingstoke, GB

Download summary PDF View on FDA.gov ↗

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Recalls naming K060286

K-number listed on FDA's recall record

Z-1075-2025 — Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797Class II·Ongoing·Oxoid Limited·20241223

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060286.

Data sourced from openFDA. This site is unofficial and independent of the FDA.