OFLOXACIN, 5 MCG SENSI-DISC— 510(k) K910506

Name: FDA 510(k) clearance K910506
Creator: U.S. Food and Drug Administration
Published: 1991-03-04

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K910506 for OFLOXACIN, 5 MCG SENSI-DISC, Substantially Equivalent on 1991-03-04. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code JTN
Device class: Class 2
Regulation: 21 CFR 866.1620
Advisory panel: Microbiology
Date received: 1991-02-05
Decision date: 1991-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin Lakes, NJ, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K910506

K-number listed on FDA's recall record

Z-1036-2024 — BD BBL Sensi Disc Ofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231672¿Class II·Ongoing·Becton Dickinson & Co.·20240108

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K910506.

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