AZITHROMYCIN, 15 MCG, SENSI DISC— 510(k) K921420

Name: FDA 510(k) clearance K921420
Creator: U.S. Food and Drug Administration
Published: 1992-05-08

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K921420 for AZITHROMYCIN, 15 MCG, SENSI DISC, Substantially Equivalent on 1992-05-08. 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: 1992-03-24
Decision date: 1992-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cockeysville, MD, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K921420

K-number listed on FDA's recall record

Z-1015-2024 — BD BBL Sensi Disc Azithromycin -15 ¿g, Catalog Number 231682¿used for semi-quantitative in vitro susceptibility testing.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 K921420.

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