GC-LECT(TM)— 510(k) K864803

Name: FDA 510(k) clearance K864803
Creator: U.S. Food and Drug Administration
Published: 1987-02-03

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K864803 for GC-LECT(TM), Substantially Equivalent on 1987-02-03. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code JTY
Device class: Class 2
Regulation: 21 CFR 866.2410
Advisory panel: Microbiology
Date received: 1986-12-09
Decision date: 1987-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin Lakes, NJ, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K864803

K-number listed on FDA's recall record

Z-2869-2018 — BD BBL GC-Lect Agar; Cat. No. 297715 The device is a selective medium providing enhanced growth and recovery of Neisseria gonorrhoeae and better inhibition of contamination bacteria and fungi.Class II·Terminated·Becton Dickinson & Co.·20180621

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K864803.

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