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
49–68 of 68
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