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
49–68 of 68
Cleared Feb 16, 1996
BACTEC LYTIC/10 ANAEROBIC/F CULTURE VIALS
K954925
Becton Dickinson Diagnostic Instrument Systems
Microbiology · 113d
Cleared Feb 16, 1996
BACTEC PEDS PLUS/F CULTURE VIALS
K954927
Becton Dickinson Diagnostic Instrument Systems
Microbiology · 113d
Cleared Feb 16, 1996
BACTEC CULTURE VIALS, LYTIC, ANAEROBIC
K954930
Becton Dickinson Diagnostic Instrument Systems
Microbiology · 113d
Cleared Feb 08, 1996
BACTEC PEDS PLUS CLUTURE VIALS
K954924
Becton Dickinson Diagnostic Instrument Systems
Microbiology · 105d
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
Cleared Apr 22, 1992
BACTEC PLUS AEROBIC/F AND ANAEROBIC/F MEDIA
K921133
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 43d
Cleared Apr 17, 1992
BACTEC FOS CULTURE SUPPLEMENT
K920933
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 49d
Cleared Mar 12, 1991
BACT/ALERT (TM)
K903505
Organon Teknika Corp.
Microbiology · 221d
Cleared Jan 03, 1984
PENASE
K833888
Oxoid U.S.A., Inc.
Microbiology · 55d
Cleared Nov 10, 1981
BACTEC RESIN CULTURE MED. 16A
K812315
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 85d
Cleared Apr 03, 1981
ANTIMICROBIAL REMOVAL DEVICE
K810613
Marion Laboratories, Inc.
Microbiology · 28d