DIRECTIGEN MENNINGITIS TEST KIT— 510(k) K841308

Name: FDA 510(k) clearance K841308
Creator: U.S. Food and Drug Administration
Published: 1984-05-02

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K841308 for DIRECTIGEN MENNINGITIS TEST KIT, Substantially Equivalent on 1984-05-02. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code GTI
Device class: Class 2
Regulation: 21 CFR 866.3390
Advisory panel: Microbiology
Date received: 1984-03-30
Decision date: 1984-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GTI

view all

K920274 — DIRECTIGEN NEISSERIA MENINGITIDIS TEST1992-03-18

More clearances from Bd Becton Dickinson Vacutainer Systems Preanalytic

view all

K003062 — BACTEC MGIT 960 SIR KITS2001-06-06
K003553 — 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE2001-03-21
K003461 — BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE2001-02-01
K002938 — B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/162000-11-29
K001364 — BD DIRECTIGEN FLU A+B2000-06-28

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