Cleared Traditional

BACTEC MGIT 960 SYSTEM

K974883 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology
May 1998
Decision
122d
Days
Class 1
Risk

About This 510(k) Submission

K974883 is an FDA 510(k) clearance for the BACTEC MGIT 960 SYSTEM, a System, Blood Culturing (Class I — General Controls, product code MDB), submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Cockeysville, US). The FDA issued a Cleared decision on May 1, 1998, 122 days after receiving the submission on December 30, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2560.

Submission Details

510(k) Number K974883 FDA.gov
FDA Decision Cleared SESE
Date Received December 30, 1997
Decision Date May 01, 1998
Days to Decision 122 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code MDB — System, Blood Culturing
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2560

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