FDA Product Code
FDA Product Code MDB — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Microbiology
- 21 CFR Citation
- 866.2560
510(k) Clearances — 68 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260213 | BD BACTEC FXI Culture System | BD Diagnostic Systems | 2026-05-28 | Traditional | PDF ↗ |
| K222591 | BD BACTEC Plus Aerobic/F Culture Vials | Becton, Dickinson and Company | 2023-03-24 | Special | PDF ↗ |
| K222559 | BD BACTEC Myco/F Lytic Culture Vials | Becton, Dickinson and Company | 2023-03-24 | Traditional | PDF ↗ |
| K190405 | BACT/ALERT MP Reagent System | bioMerieux, Inc. | 2019-05-15 | Traditional | PDF ↗ |
| K183166 | BacT/ALERT FA Plus; BacT/ALERT PF Plus | bioMerieux, Inc. | 2019-02-11 | Traditional | PDF ↗ |
| K173873 | BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial | Becton, Dickinson and Company | 2018-03-16 | Traditional | PDF ↗ |
| K161816 | BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO | bioMerieux, Inc. | 2017-03-28 | Traditional | PDF ↗ |
| K161810 | BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial | Becton Dickinson | 2017-02-09 | Traditional | PDF ↗ |
| K161306 | BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial | Becton Dickinson | 2016-08-08 | Traditional | PDF ↗ |
| K151866 | BD BACTEC Peds Plus/F Culture Vials (plastic) | Becton, Dickinson and Company | 2016-02-25 | Traditional | PDF ↗ |
| K141810 | BD BACTEC PLUS ANAEROBIC/F (PLASTIC) | Becton, Dickinson and Company | 2014-12-10 | Traditional | PDF ↗ |
| K123903 | BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic) | Becton, Dickinson & CO | 2013-05-13 | Traditional | PDF ↗ |
| K121455 | BACT/ALERT FN PLUS CULTURE BOTTLE | bioMerieux, Inc. | 2013-01-25 | Traditional | PDF ↗ |
| K121446 | BACT/ALERT PF PLUS CULTURE BOTTLE | bioMerieux, Inc. | 2013-01-25 | Traditional | PDF ↗ |
| K121461 | BACT/ALERT FA PLUS CULTURE BOTTLE | bioMerieux, Inc. | 2013-01-22 | Traditional | PDF ↗ |
| K120994 | BD BACTEC Plus PRIME Aerobic/F Culture Vials | Becton, Dickinson and Company | 2012-08-07 | Traditional | PDF ↗ |
| K113558 | BD BACTEC Plus Aerobic/F Culture Vials (plastic) | Becton, Dickinson and Company | 2012-03-16 | Traditional | PDF ↗ |
| K083572 | BD BACTEC Plus Aerobic/F Culture Vials | Becton, Dickinson & CO | 2008-12-24 | Special | PDF ↗ |
| K032306 | VERSATREK | Trek Diagnostic Systems, Inc. | 2003-08-22 | Special | PDF ↗ |
| K031737 | BACT/ALERT MP CULTURE BOTTLES (PLASTIC) | bioMerieux, Inc. | 2003-07-14 | Traditional | PDF ↗ |
| K021123 | BACT/ALERT SN CULTURE BOTTLE | bioMerieux, Inc. | 2002-04-26 | Traditional | PDF ↗ |
| K020923 | BACT/ALERT PF CULTURE BOTTLE | bioMerieux, Inc. | 2002-04-18 | Traditional | PDF ↗ |
| K020931 | BACT/ALERT SA CULTURE BOTTLE | bioMerieux, Inc. | 2002-04-18 | Traditional | PDF ↗ |
| K020815 | BACT/ALERT FN CULTURE BOTTLE | bioMerieux, Inc. | 2002-04-18 | Traditional | PDF ↗ |
| K020813 | BACT/ALERT FA CULTURE BOTTLE | bioMerieux, Inc. | 2002-04-17 | Traditional | PDF ↗ |
| K000378 | BACT/ALERT MB CULTURE BOTTLE | Organon Teknika Corp. | 2000-03-02 | Traditional | PDF ↗ |
| K994343 | BACT/ALERT SV | Organon Teknika Corp. | 2000-02-10 | Traditional | PDF ↗ |
| K993423 | BACT/ALERT SA | Organon Teknika Corp. | 1999-12-15 | Traditional | PDF ↗ |
| K993576 | BACT/ALERT MP PROCESS BOTTLE | Organon Teknika Corp. | 1999-12-14 | Traditional | PDF ↗ |
| K993421 | BACT/ALERT SN | Organon Teknika Corp. | 1999-12-14 | Traditional | PDF ↗ |
| K992432 | BACT/ALERT FN | Organon Teknika Corp. | 1999-09-24 | Traditional | PDF ↗ |
| K992401 | BACT/ALERT PF | Organon Teknika Corp. | 1999-09-03 | Traditional | PDF ↗ |
| K992400 | BACTALERT FA | Organon Teknika Corp. | 1999-09-03 | Traditional | PDF ↗ |
| K983772 | MB/BACT BLOOD CULTURE BOTTLE | Organon Teknika Corp. | 1999-01-13 | Traditional | PDF ↗ |
| K982263 | MB/BACT BLOOD CULTURE BOTTLE | Organon Teknika Corp. | 1998-08-18 | Traditional | PDF ↗ |
| K981736 | BACT/ALERT 3D MICROBIAL DETECTION SYSTEM | Organon Teknika Corp. | 1998-07-24 | Traditional | PDF ↗ |
| K974883 | BACTEC MGIT 960 SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998-05-01 | Traditional | PDF ↗ |
| K970333 | BACTEC MYCO/F LYTIC CULTURE VIALS | Becton Dickinson Microbiology Systems | 1998-01-28 | Traditional | PDF ↗ |
| K970512 | BACTEC MYCO/F LYTIC CULTURE VIALS | Becton Dickinson Microbiology Systems | 1998-01-08 | Traditional | PDF ↗ |
| K973325 | BACT/ALERT FAN CULTURE BOTTLES | Organon Teknika Corp. | 1997-12-02 | Traditional | PDF ↗ |
| K973305 | BACT/ALERT CULTURE BOTTLES | Organon Teknika Corp. | 1997-11-17 | Traditional | PDF ↗ |
| K972758 | BACTEC MYCO/F-SPUTA CULTURE VIALS | Becton Dickinson Microbiology Systems | 1997-08-08 | Traditional | PDF ↗ |
| K972756 | MODIFICATION OF EST CULTURE SYSTEM II - MYCO | Accumed Intl., Inc. | 1997-08-01 | Traditional | PDF ↗ |
| K954932 | BBL MGIT PRODUCTS | Becton Dickinson Diagnostic Instrument Systems | 1996-08-21 | Traditional | PDF ↗ |
| K962210 | BACTEC 9050 SYSTEM | Becton Dickinson Diagnostic Instrument Systems | 1996-08-08 | Traditional | PDF ↗ |
| K954468 | MB/BACT MYCROBACTERIA DETECTION SYSTEM | Organon Teknika Corp. | 1996-07-22 | Traditional | PDF ↗ |
| K946268 | BACTEC(R) 9000TB SYSTEM | Becton Dickinson Diagnostic Instrument Systems | 1996-05-21 | Traditional | PDF ↗ |
| K954925 | BACTEC LYTIC/10 ANAEROBIC/F CULTURE VIALS | Becton Dickinson Diagnostic Instrument Systems | 1996-02-16 | Traditional | PDF ↗ |
| K954930 | BACTEC CULTURE VIALS, LYTIC, ANAEROBIC | Becton Dickinson Diagnostic Instrument Systems | 1996-02-16 | Traditional | PDF ↗ |
| K954921 | BACTEC STANDARD/10 AEROBIC/F CULTURE VIALS | Becton Dickinson Diagnostic Instrument Systems | 1996-02-16 | Traditional | PDF ↗ |
| K954927 | BACTEC PEDS PLUS/F CULTURE VIALS | Becton Dickinson Diagnostic Instrument Systems | 1996-02-16 | Traditional | PDF ↗ |
| K954924 | BACTEC PEDS PLUS CLUTURE VIALS | Becton Dickinson Diagnostic Instrument Systems | 1996-02-08 | Traditional | PDF ↗ |
| K953129 | ESP CULTURE SYSTEM - MYCO | Difco Laboratories, Inc. | 1995-12-26 | Traditional | PDF ↗ |
| K944594 | BACT/ALERT FAN CULTURE BOTTLE | Organon Teknika Corp. | 1995-02-17 | Traditional | PDF ↗ |
| K935711 | BACT/ALERT FAN AEROBIC CULTURE BOTTLE | Organon Teknika Corp. | 1994-08-30 | Traditional | PDF ↗ |
| K934593 | BACT/ALERT 120 | Organon Teknika Corp. | 1994-02-09 | Traditional | PDF ↗ |
| K926304 | BACTEC PEDS PLUS/F | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993-03-04 | Traditional | PDF ↗ |
| K925693 | EZ VIEW | Difco Laboratories, Inc. | 1993-01-15 | Traditional | PDF ↗ |
| K921637 | ESP BLOOD CULTURE SYSTEM | Difco Laboratories, Inc. | 1992-07-14 | Traditional | PDF ↗ |
| K922475 | BACTEC 9120 SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-07-01 | Traditional | PDF ↗ |
| K920249 | BACT/ALERT PEDI-BACT | Organon Teknika Corp. | 1992-04-23 | Traditional | PDF ↗ |
| K915796 | BACTEC 9240 SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-04-22 | Traditional | PDF ↗ |
| K921133 | BACTEC PLUS AEROBIC/F AND ANAEROBIC/F MEDIA | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-04-22 | Traditional | PDF ↗ |
| K920933 | BACTEC FOS CULTURE SUPPLEMENT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-04-17 | Traditional | PDF ↗ |
| K903505 | BACT/ALERT (TM) | Organon Teknika Corp. | 1991-03-12 | Traditional | PDF ↗ |
| K833888 | PENASE | Oxoid U.S.A., Inc. | 1984-01-03 | Traditional | PDF ↗ |
| K812315 | BACTEC RESIN CULTURE MED. 16A | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-11-10 | Traditional | PDF ↗ |
| K810613 | ANTIMICROBIAL REMOVAL DEVICE | Marion Laboratories, Inc. | 1981-04-03 | Traditional | PDF ↗ |
Product code MDB · Class I · Microbiology. Data: openFDA.