MDB — System, Blood Culturing Class I
FDA product code MDB covers "System, Blood Culturing", a Class I medical device regulated under 21 CFR 866.2560. Submissions are reviewed by the Microbiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MDB
- Device Class
- Class I
- Regulation Number
- 866.2560
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260213 | bd diagnostic systems | BD BACTEC FXI Culture System | May 28, 2026 |
| K222591 | becton, dickinson and | BD BACTEC Plus Aerobic/F Culture Vials | March 24, 2023 |
| K222559 | becton, dickinson and | BD BACTEC Myco/F Lytic Culture Vials | March 24, 2023 |
| K190405 | biomerieux | BACT/ALERT MP Reagent System | May 15, 2019 |
| K183166 | biomerieux | BacT/ALERT FA Plus; BacT/ALERT PF Plus | February 11, 2019 |
| K173873 | becton, dickinson and | BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a | March 16, 2018 |
| K161816 | biomerieux | BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO | March 28, 2017 |
| K161810 | becton dickinson | BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a P | February 9, 2017 |
| K161306 | becton dickinson | BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Pl | August 8, 2016 |
| K151866 | becton, dickinson and | BD BACTEC Peds Plus/F Culture Vials (plastic) | February 25, 2016 |
| K141810 | becton, dickinson and | BD BACTEC PLUS ANAEROBIC/F (PLASTIC) | December 10, 2014 |
| K123903 | becton, dickinson and | BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic) | May 13, 2013 |
| K121455 | biomerieux | BACT/ALERT FN PLUS CULTURE BOTTLE | January 25, 2013 |
| K121446 | biomerieux | BACT/ALERT PF PLUS CULTURE BOTTLE | January 25, 2013 |
| K121461 | biomerieux | BACT/ALERT FA PLUS CULTURE BOTTLE | January 22, 2013 |
| K120994 | becton, dickinson and | BD BACTEC Plus PRIME Aerobic/F Culture Vials | August 7, 2012 |
| K113558 | becton, dickinson and | BD BACTEC Plus Aerobic/F Culture Vials (plastic) | March 16, 2012 |
| K083572 | becton, dickinson and | BD BACTEC Plus Aerobic/F Culture Vials | December 24, 2008 |
| K032306 | trek diagnostic systems | VERSATREK | August 22, 2003 |
| K031737 | biomerieux | BACT/ALERT MP CULTURE BOTTLES (PLASTIC) | July 14, 2003 |