Cleared Traditional

BACTEC FUNGAL MEDIUM

K954923 · Becton Dickinson Diagnostic Instrument Systems · Microbiology
Nov 1996
Decision
392d
Days
Class 1
Risk

About This 510(k) Submission

K954923 is an FDA 510(k) clearance for the BACTEC FUNGAL MEDIUM, a Monitor, Microbial Growth (Class I — General Controls, product code JTA), submitted by Becton Dickinson Diagnostic Instrument Systems (Sparks, US). The FDA issued a Cleared decision on November 21, 1996, 392 days after receiving the submission on October 26, 1995. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2560.

Submission Details

510(k) Number K954923 FDA.gov
FDA Decision Cleared SESE
Date Received October 26, 1995
Decision Date November 21, 1996
Days to Decision 392 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code JTA — Monitor, Microbial Growth
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2560

Similar Devices — JTA Monitor, Microbial Growth

All 10
BACTEC NR-860
K910835 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1991
BACTEC(R) NR-660 HIGH PERFORMANCE SYSTEM
K865021 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1987
BACTEC NR-730 BACTERIAL DETECTION SYSTEM
K853011 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1985
RADIOMETRIC BLOOD CULTURE VIALS, AEROBE
K842874 · American Micro Scan · Sep 1984
BECTEC NR-660 BACTERIAL DETECT SYS
K842279 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1984
BAC-T-SCREEN
K833917 · Marion Laboratories, Inc. · Jan 1984