Bact/Alert Fa Plus Culture Bottle
FDA 510(k) K121461 · bioMerieux, Inc.
510(k) numberK121461
Submission
- Device name
- Bact/Alert Fa Plus Culture Bottle
- Applicant
- bioMerieux, Inc.
Durham, NC, US - Received
- May 17, 2012
- Decision date
- January 22, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MDB – System, Blood Culturing
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2560
- Specialty
- Microbiology
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| K161816 | BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUOMDB · Traditional | bioMerieux, Inc. | 03/28/2017SE |
| K161810 | BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic…MDB · Traditional | Becton Dickinson | 02/09/2017SE |
| K161306 | BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic VialMDB · Traditional | Becton Dickinson | 08/08/2016SE |
| K151866 | BD BACTEC Peds Plus/F Culture Vials (plastic)MDB · Traditional | Becton, Dickinson and Company | 02/25/2016SE |
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Questions and answers
When was Bact/Alert Fa Plus Culture Bottle cleared by the FDA?
Bact/Alert Fa Plus Culture Bottle (K121461) received a 510(k) decision of Substantially Equivalent on January 22, 2013, 250 days after the submission was received.
What is the product code of K121461?
The FDA product code is MDB – System, Blood Culturing, a Class I (low risk) device regulated under 21 CFR 866.2560.