510(k) K120994
- Device
- BD BACTEC PLUS PRIME AEROBIC/F
- Applicant
- Becton, Dickinson And Company
- 510(k) number
- K120994
- Product code
- MDB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-08-07
- Date received
- 2012-04-02
- Regulation
- 866.2560
- Classification name
- System, Blood Culturing
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Paul Swift
- Address
- 7 Loveton Cir., Mc 614 Sparks MD US 21152 21152
FDA Registration Numbers#
- 1119779
- 3016678045
- 3003030793
- 3013188547
- 3002769706
- 3003542872
- 1950204
- 3013718871
- 1423662
- 1530126
- 1025402
- 2124274
- 3009637528
- 1924669
- 1111096
- 3031977134
- 3012421607
- 3013557562
- 2647876
Source Documents#
Other 510(k) Records For Product Code MDB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K222591 | BD BACTEC™ Plus Aerobic/F Culture Vials | Becton, Dickinson and Company | 2023-03-24 |
| K222559 | BD BACTEC™ Myco/F Lytic Culture Vials | Becton, Dickinson and Company | 2023-03-24 |
| K190405 | BACT/ALERT MP Reagent System | bioMerieux, Inc. | 2019-05-15 |
| K183166 | BacT/ALERT FA Plus; BacT/ALERT PF Plus | bioMerieux, Inc. | 2019-02-11 |
| 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 |
| K161816 | BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO | bioMerieux, Inc. | 2017-03-28 |
| K161810 | BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial | Becton Dickinson | 2017-02-09 |
| K161306 | BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial | Becton Dickinson | 2016-08-08 |
| K151866 | BD BACTEC Peds Plus/F Culture Vials (plastic) | Becton, Dickinson and Company | 2016-02-25 |
| K141810 | BD BACTEC PLUS ANAEROBIC/F (PLASTIC) | Becton, Dickinson and Company | 2014-12-10 |
| K123903 | BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic) | Becton, Dickinson & CO | 2013-05-13 |
| K121446 | BACT/ALERT PF PLUS CULTURE BOTTLE | bioMerieux, Inc. | 2013-01-25 |
| K121455 | BACT/ALERT FN PLUS CULTURE BOTTLE | bioMerieux, Inc. | 2013-01-25 |
| K121461 | BACT/ALERT FA PLUS CULTURE BOTTLE | bioMerieux, Inc. | 2013-01-22 |
| K113558 | BD BACTEC Plus Aerobic/F Culture Vials (plastic) | Becton, Dickinson and Company | 2012-03-16 |
Legacy Summary#
summary
FDA Review#
Decision Summary