Cleared Traditional

B-D AUTO-INJECTOR

K974678 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General Hospital
May 1998
Decision
165d
Days
Class 2
Risk

About This 510(k) Submission

K974678 is an FDA 510(k) clearance for the B-D AUTO-INJECTOR, a Introducer, Syringe Needle (Class II — Special Controls, product code KZH), submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on May 29, 1998, 165 days after receiving the submission on December 15, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6920.

Submission Details

510(k) Number K974678 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 1997
Decision Date May 29, 1998
Days to Decision 165 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code KZH — Introducer, Syringe Needle
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6920