CEFPODOXIME 10 MCG, SENSI DISC— 510(k) K924797

Name: FDA 510(k) clearance K924797
Creator: U.S. Food and Drug Administration
Published: 1992-11-02

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K924797 for CEFPODOXIME 10 MCG, SENSI DISC, Substantially Equivalent on 1992-11-02. 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: 1992-09-24
Decision date: 1992-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cockeysville, MD, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K924797

K-number listed on FDA's recall record

Z-1021-2024 — BD BBL Sensi Disc Cefpodoxime - 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231673 and 231674¿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 K924797.

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