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 Diagnostic Instrument Systems.

68
Total
68
Cleared
122d
Avg days
1981
Since
68 devices
25–48 of 68
Cleared Apr 17, 2002
BACT/ALERT FA CULTURE BOTTLE
K020813
bioMerieux, Inc.
Microbiology · 35d
Cleared Mar 02, 2000
BACT/ALERT MB CULTURE BOTTLE
K000378
Organon Teknika Corp.
Microbiology · 24d
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 Jan 28, 1998
BACTEC MYCO/F LYTIC CULTURE VIALS
K970333
Becton Dickinson Microbiology Systems
Microbiology · 365d
Cleared Jan 08, 1998
BACTEC MYCO/F LYTIC CULTURE VIALS
K970512
Becton Dickinson Microbiology Systems
Microbiology · 331d
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 Aug 08, 1997
BACTEC MYCO/F-SPUTA CULTURE VIALS
K972758
Becton Dickinson Microbiology Systems
Microbiology · 53d
Cleared Aug 01, 1997
MODIFICATION OF EST CULTURE SYSTEM II - MYCO
K972756
Accumed Intl., Inc.
Microbiology · 63d
Cleared Aug 21, 1996
BBL MGIT PRODUCTS
K954932
Becton Dickinson Diagnostic Instrument Systems
Microbiology · 299d
Cleared Aug 08, 1996
BACTEC 9050 SYSTEM
K962210
Becton Dickinson Diagnostic Instrument Systems
Microbiology · 59d
Cleared Jul 22, 1996
MB/BACT MYCROBACTERIA DETECTION SYSTEM
K954468
Organon Teknika Corp.
Microbiology · 300d
Cleared May 21, 1996
BACTEC(R) 9000TB SYSTEM
K946268
Becton Dickinson Diagnostic Instrument Systems
Microbiology · 515d
Cleared Feb 16, 1996
BACTEC STANDARD/10 AEROBIC/F CULTURE VIALS
K954921
Becton Dickinson Diagnostic Instrument Systems
Microbiology · 113d