IMIPENEM 10 MCG SENSI-DISC,CAT. # 31644/31645— 510(k) K855106

Name: FDA 510(k) clearance K855106
Creator: U.S. Food and Drug Administration
Published: 1986-03-06

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K855106 for IMIPENEM 10 MCG SENSI-DISC,CAT. # 31644/31645, Substantially Equivalent on 1986-03-06. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code JTT
Device class: Class 2
Regulation: 21 CFR 866.1640
Advisory panel: Microbiology
Date received: 1985-12-23
Decision date: 1986-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paramus, NJ, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K855106

K-number listed on FDA's recall record

Z-1031-2024 — BD BBL Sensi Disc Imipenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231644 and 231645¿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 K855106.

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