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Panels › Microbiology › Product code MDB · Class 1

System, Blood Culturing

Regulation 866.2560

1510(k)s in 12 months (68 all time)
0recalls in 12 months (76 all time)
32recalls that name a 510(k)
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Top companies in MDB

Decided510(k)Device and applicantCode
May 28, 2026K260213BD BACTEC FXI Culture System
BD Diagnostic Systems
MDB
Mar 24, 2023K222591BD BACTEC™ Plus Aerobic/F Culture Vials
Becton, Dickinson and Company
MDB
Mar 24, 2023K222559BD BACTEC™ Myco/F Lytic Culture Vials
Becton, Dickinson and Company
MDB
May 15, 2019K190405BACT/ALERT MP Reagent System
bioMerieux, Inc.
MDB
Feb 11, 2019K183166BacT/ALERT FA Plus; BacT/ALERT PF Plus
bioMerieux, Inc.
MDB
Mar 16, 2018K173873BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial
Becton, Dickinson and Company
MDB
Mar 28, 2017K161816BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO
bioMerieux, Inc.
MDB
Feb 9, 2017K161810BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial
Becton Dickinson
MDB
Aug 8, 2016K161306BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial
Becton Dickinson
MDB
Feb 25, 2016K151866BD BACTEC Peds Plus/F Culture Vials (plastic)
Becton, Dickinson and Company
MDB
Dec 10, 2014K141810BD BACTEC PLUS ANAEROBIC/F (PLASTIC)
Becton, Dickinson and Company
MDB
May 13, 2013K123903BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic)
Becton, Dickinson & CO
MDB
Jan 25, 2013K121455BACT/ALERT FN PLUS CULTURE BOTTLE
bioMerieux, Inc.
MDB
Jan 25, 2013K121446BACT/ALERT PF PLUS CULTURE BOTTLE
bioMerieux, Inc.
MDB
Jan 22, 2013K121461BACT/ALERT FA PLUS CULTURE BOTTLE
bioMerieux, Inc.
MDB
Aug 7, 2012K120994BD BACTEC Plus PRIME Aerobic/F Culture Vials
Becton, Dickinson and Company
MDB
Mar 16, 2012K113558BD BACTEC Plus Aerobic/F Culture Vials (plastic)
Becton, Dickinson and Company
MDB
Dec 24, 2008K083572BD BACTEC Plus Aerobic/F Culture Vials
Becton, Dickinson & CO
MDB
Aug 22, 2003K032306VERSATREK
Trek Diagnostic Systems, Inc.
MDB
Jul 14, 2003K031737BACT/ALERT MP CULTURE BOTTLES (PLASTIC)
bioMerieux, Inc.
MDB
Apr 26, 2002K021123BACT/ALERT SN CULTURE BOTTLE
bioMerieux, Inc.
MDB
Apr 18, 2002K020931BACT/ALERT SA CULTURE BOTTLE
bioMerieux, Inc.
MDB
Apr 18, 2002K020923BACT/ALERT PF CULTURE BOTTLE
bioMerieux, Inc.
MDB
Apr 18, 2002K020815BACT/ALERT FN CULTURE BOTTLE
bioMerieux, Inc.
MDB
Apr 17, 2002K020813BACT/ALERT FA CULTURE BOTTLE
bioMerieux, Inc.
MDB
Mar 2, 2000K000378BACT/ALERT MB CULTURE BOTTLE
Organon Teknika Corp.
MDB
Feb 10, 2000K994343BACT/ALERT SV
Organon Teknika Corp.
MDB
Dec 15, 1999K993423BACT/ALERT SA
Organon Teknika Corp.
MDB
Dec 14, 1999K993576BACT/ALERT MP PROCESS BOTTLE
Organon Teknika Corp.
MDB
Dec 14, 1999K993421BACT/ALERT SN
Organon Teknika Corp.
MDB
Sep 24, 1999K992432BACT/ALERT FN
Organon Teknika Corp.
MDB
Sep 3, 1999K992401BACT/ALERT PF
Organon Teknika Corp.
MDB
Sep 3, 1999K992400BACTALERT FA
Organon Teknika Corp.
MDB
Jan 13, 1999K983772MB/BACT BLOOD CULTURE BOTTLE
Organon Teknika Corp.
MDB
Aug 18, 1998K982263MB/BACT BLOOD CULTURE BOTTLE
Organon Teknika Corp.
MDB
Jul 24, 1998K981736BACT/ALERT 3D MICROBIAL DETECTION SYSTEM
Organon Teknika Corp.
MDB
May 1, 1998K974883BACTEC MGIT 960 SYSTEM
Bd Becton Dickinson Vacutainer Systems Preanalytic
MDB
Jan 28, 1998K970333BACTEC MYCO/F LYTIC CULTURE VIALS
Becton Dickinson Microbiology Systems
MDB
Jan 8, 1998K970512BACTEC MYCO/F LYTIC CULTURE VIALS
Becton Dickinson Microbiology Systems
MDB
Dec 2, 1997K973325BACT/ALERT FAN CULTURE BOTTLES
Organon Teknika Corp.
MDB
Nov 17, 1997K973305BACT/ALERT CULTURE BOTTLES
Organon Teknika Corp.
MDB
Aug 8, 1997K972758BACTEC MYCO/F-SPUTA CULTURE VIALS
Becton Dickinson Microbiology Systems
MDB
Aug 1, 1997K972756MODIFICATION OF EST CULTURE SYSTEM II - MYCO
Accumed Intl., Inc.
MDB
Aug 21, 1996K954932BBL MGIT PRODUCTS
Becton Dickinson Diagnostic Instrument Systems
MDB
Aug 8, 1996K962210BACTEC 9050 SYSTEM
Becton Dickinson Diagnostic Instrument Systems
MDB
Jul 22, 1996K954468MB/BACT MYCROBACTERIA DETECTION SYSTEM
Organon Teknika Corp.
MDB
May 21, 1996K946268BACTEC(R) 9000TB SYSTEM
Becton Dickinson Diagnostic Instrument Systems
MDB
Feb 16, 1996K954930BACTEC CULTURE VIALS, LYTIC, ANAEROBIC
Becton Dickinson Diagnostic Instrument Systems
MDB
Feb 16, 1996K954927BACTEC PEDS PLUS/F CULTURE VIALS
Becton Dickinson Diagnostic Instrument Systems
MDB
Feb 16, 1996K954925BACTEC LYTIC/10 ANAEROBIC/F CULTURE VIALS
Becton Dickinson Diagnostic Instrument Systems
MDB

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