CEFTAZIDIME 30MCG. SENI-DISC— 510(k) K852873

Name: FDA 510(k) clearance K852873
Creator: U.S. Food and Drug Administration
Published: 1985-08-19

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K852873 for CEFTAZIDIME 30MCG. SENI-DISC, Substantially Equivalent on 1985-08-19. 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: 1985-07-08
Decision date: 1985-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paramus, NJ, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K852873

K-number listed on FDA's recall record

Z-1023-2024 — BD BBL Sensi Disc Ceftazidime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231632¿and 231633¿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 K852873.

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