FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K972756 |
ACCUMED INTL., INC. |
MODIFICATION OF EST CULTURE SYSTEM II - MYCO |
08/01/1997 |
K974883 |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
BACTEC MGIT 960 SYSTEM |
05/01/1998 |
K161306 |
BECTON DICKINSON |
BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial |
08/08/2016 |
K161810 |
BECTON DICKINSON |
BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial |
02/09/2017 |
K123903 |
BECTON DICKINSON & CO. |
BD BACTEC LYTIC/10 ANAEROBIC/F (PLASTIC) |
05/13/2013 |
K151866 |
BECTON DICKINSON AND COMPANY |
BD BACTEC Peds Plus/F Culture Vials (plastic) |
02/25/2016 |
K173873 |
Becton Dickinson and Company |
BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial |
03/16/2018 |
K962210 |
BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS |
BACTEC 9050 SYSTEM |
08/08/1996 |
K954930 |
BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS |
BACTEC CULTURE VIALS, LYTIC, ANAEROBIC |
02/16/1996 |
K954925 |
BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS |
BACTEC LYTIC/10 ABAERIBIC/F CULTURE VIALS |
02/16/1996 |
K954924 |
BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS |
BACTEC PEDS PLUS CLUTURE VIALS |
02/08/1996 |
K954927 |
BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS |
BACTEC PEDS PLUS/F CULTURE VIALS |
02/16/1996 |
K954921 |
BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS |
BACTEC STANDARD/10 AEROBIC/F CULTURE VIALS |
02/16/1996 |
K946268 |
BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS |
BACTEC(R) 9000TB SYSTEM |
05/21/1996 |
K954932 |
BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS |
BBL MGIT PRODUCTS |
08/21/1996 |
K970333 |
BECTON DICKINSON MICROBIOLOGY SYSTEMS |
BACTEC MYCO/F LYTIC CULTURE VIALS |
01/28/1998 |
K970512 |
BECTON DICKINSON MICROBIOLOGY SYSTEMS |
BACTEC MYCO/F LYTIC CULTURE VIALS |
01/08/1998 |
K972758 |
BECTON DICKINSON MICROBIOLOGY SYSTEMS |
BACTEC MYCO/F-SPUTA CULTURE VIALS |
08/08/1997 |
K083572 |
BECTON, DICKINSON & CO. |
BD BACTEC PLUS AEROBIC/F BLOOD CULTURE MEDIUM |
12/24/2008 |
K222559 |
Becton, Dickinson and Company |
BD BACTECÖ Myco/F Lytic Culture Vials |
03/24/2023 |
K113558 |
Becton, Dickinson and Company |
BD BACTEC PLUS AEROBIC/F (PLASTIC) |
03/16/2012 |
K141810 |
Becton, Dickinson and Company |
BD BACTEC PLUS ANAEROBIC/F (PLASTIC) |
12/10/2014 |
K120994 |
Becton, Dickinson and Company |
BD BACTEC PLUS PRIME AEROBIC/F |
08/07/2012 |
K222591 |
Becton, Dickinson and Company |
BD BACTECÖ Plus Aerobic/F Culture Vials |
03/24/2023 |
K020813 |
BIOMERIEUX, INC. |
BACT/ALERT FA CULTURE BOTTLE |
04/17/2002 |
K121461 |
BIOMERIEUX, INC. |
BACT/ALERT FA PLUS CULTURE BOTTLE |
01/22/2013 |
K183166 |
bioMerieux, Inc. |
BacT/ALERT FA Plus; BacT/ALERT PF Plus |
02/11/2019 |
K020815 |
BIOMERIEUX, INC. |
BACT/ALERT FN CULTURE BOTTLE |
04/18/2002 |
K121455 |
BIOMERIEUX, INC. |
BACT/ALERT FN PLUS CULTURE BOTTLE |
01/25/2013 |
K031737 |
BIOMERIEUX, INC. |
BACT/ALERT MP CULTURE BOTTLES (PLASTIC) |
07/14/2003 |
K190405 |
bioMerieux, Inc. |
BACT/ALERT MP Reagent System |
05/15/2019 |
K020923 |
BIOMERIEUX, INC. |
BACT/ALERT PF CULTURE BOTTLE |
04/18/2002 |
K121446 |
BIOMERIEUX, INC. |
BACT/ALERT PF PLUS CULTURE BOTTLE |
01/25/2013 |
K020931 |
BIOMERIEUX, INC. |
BACT/ALERT SA CULTURE BOTTLE |
04/18/2002 |
K021123 |
BIOMERIEUX, INC. |
BACT/ALERT SN CULTURE BOTTLE |
04/26/2002 |
K161816 |
bioMerieux, Inc. |
BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO |
03/28/2017 |
K981736 |
ORGANON TEKNIKA CORP. |
BACT/ALERT 3D MICROBIAL DETECTION SYSTEM |
07/24/1998 |
K973305 |
ORGANON TEKNIKA CORP. |
BACT/ALERT CULTURE BOTTLES |
11/17/1997 |
K973325 |
ORGANON TEKNIKA CORP. |
BACT/ALERT FAN CULTURE BOTTLES |
12/02/1997 |
K992432 |
ORGANON TEKNIKA CORP. |
BACT/ALERT FN |
09/24/1999 |
K000378 |
ORGANON TEKNIKA CORP. |
BACT/ALERT MB CULTURE BOTTLE |
03/02/2000 |
K993576 |
ORGANON TEKNIKA CORP. |
BACT/ALERT MP PROCESS BOTTLE |
12/14/1999 |
K992401 |
ORGANON TEKNIKA CORP. |
BACT/ALERT PF |
09/03/1999 |
K993423 |
ORGANON TEKNIKA CORP. |
BACT/ALERT SA |
12/15/1999 |
K993421 |
ORGANON TEKNIKA CORP. |
BACT/ALERT SN |
12/14/1999 |
K994343 |
ORGANON TEKNIKA CORP. |
BACT/ALERT SV |
02/10/2000 |
K992400 |
ORGANON TEKNIKA CORP. |
BACTALERT FA |
09/03/1999 |
K982263 |
ORGANON TEKNIKA CORP. |
MB/BACT BLOOD CULTURE BOTTLE |
08/18/1998 |
K983772 |
ORGANON TEKNIKA CORP. |
MB/BACT BLOOD CULTURE BOTTLE |
01/13/1999 |
K954468 |
ORGANON TEKNIKA CORP. |
MB/BACT MYCROBACTERIA DETECTION SYSTEM |
07/22/1996 |
K032306 |
TREK DIAGNOSTIC SYSTEMS, INC. |
VERSATREK |
08/22/2003 |