MDB · Class I · 21 CFR 866.2560

FDA Product Code MDB: System, Blood Culturing

Leading manufacturers include Organon Teknika Corp., bioMerieux, Inc. and Becton, Dickinson and Company.

68
Total
68
Cleared
122d
Avg days
1981
Since
68 devices
25–48 of 68
Cleared Feb 10, 2000
BACT/ALERT SV
K994343
Organon Teknika Corp.
Microbiology · 49d
Cleared Dec 15, 1999
BACT/ALERT SA
K993423
Organon Teknika Corp.
Microbiology · 64d
Cleared Dec 14, 1999
BACT/ALERT SN
K993421
Organon Teknika Corp.
Microbiology · 63d
Cleared Dec 14, 1999
BACT/ALERT MP PROCESS BOTTLE
K993576
Organon Teknika Corp.
Microbiology · 54d
Cleared Sep 24, 1999
BACT/ALERT FN
K992432
Organon Teknika Corp.
Microbiology · 65d
Cleared Sep 03, 1999
BACTALERT FA
K992400
Organon Teknika Corp.
Microbiology · 46d
Cleared Sep 03, 1999
BACT/ALERT PF
K992401
Organon Teknika Corp.
Microbiology · 46d
Cleared Jan 13, 1999
MB/BACT BLOOD CULTURE BOTTLE
K983772
Organon Teknika Corp.
Microbiology · 79d
Cleared Aug 18, 1998
MB/BACT BLOOD CULTURE BOTTLE
K982263
Organon Teknika Corp.
Microbiology · 50d
Cleared Jul 24, 1998
BACT/ALERT 3D MICROBIAL DETECTION SYSTEM
K981736
Organon Teknika Corp.
Microbiology · 67d
Cleared May 01, 1998
BACTEC MGIT 960 SYSTEM
K974883
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 122d
Cleared Dec 02, 1997
BACT/ALERT FAN CULTURE BOTTLES
K973325
Organon Teknika Corp.
Microbiology · 89d
Cleared Nov 17, 1997
BACT/ALERT CULTURE BOTTLES
K973305
Organon Teknika Corp.
Microbiology · 75d
Cleared Jul 22, 1996
MB/BACT MYCROBACTERIA DETECTION SYSTEM
K954468
Organon Teknika Corp.
Microbiology · 300d
Cleared Dec 26, 1995
ESP CULTURE SYSTEM - MYCO
K953129
Difco Laboratories, Inc.
Microbiology · 173d
Cleared Feb 17, 1995
BACT/ALERT FAN CULTURE BOTTLE
K944594
Organon Teknika Corp.
Microbiology · 151d
Cleared Aug 30, 1994
BACT/ALERT FAN AEROBIC CULTURE BOTTLE
K935711
Organon Teknika Corp.
Microbiology · 273d
Cleared Feb 09, 1994
BACT/ALERT 120
K934593
Organon Teknika Corp.
Microbiology · 138d
Cleared Mar 04, 1993
BACTEC PEDS PLUS/F
K926304
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 79d
Cleared Jan 15, 1993
EZ VIEW
K925693
Difco Laboratories, Inc.
Microbiology · 64d
Cleared Jul 14, 1992
ESP BLOOD CULTURE SYSTEM
K921637
Difco Laboratories, Inc.
Microbiology · 99d
Cleared Jul 01, 1992
BACTEC 9120 SYSTEM
K922475
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 36d
Cleared Apr 23, 1992
BACT/ALERT PEDI-BACT
K920249
Organon Teknika Corp.
Microbiology · 93d
Cleared Apr 22, 1992
BACTEC 9240 SYSTEM
K915796
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 120d