FDA 510(k) Applications for Medical Device Product Code "MDB"
(System, Blood Culturing)
| 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 |
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