Bactec Myco/F Lytic Culture Vials
FDA 510(k) K970333 · Becton Dickinson Microbiology Systems
510(k) numberK970333
Submission
- Device name
- Bactec Myco/F Lytic Culture Vials
- Applicant
- Becton Dickinson Microbiology Systems
Sparks, MD, US - Received
- January 28, 1997
- Decision date
- January 28, 1998
- 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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|---|---|---|---|
| K260213 | BD BACTEC FXI Culture SystemMDB · Traditional | BD Diagnostic Systems | 05/28/2026SE |
| K222591 | BD BACTEC Plus Aerobic/F Culture VialsMDB · Special | Becton, Dickinson and Company | 03/24/2023SE |
| K222559 | BD BACTEC Myco/F Lytic Culture VialsMDB · Traditional | Becton, Dickinson and Company | 03/24/2023SE |
| K190405 | BACT/ALERT MP Reagent SystemMDB · Traditional | bioMerieux, Inc. | 05/15/2019SE |
| K183166 | BacT/ALERT FA Plus; BacT/ALERT PF PlusMDB · Traditional | bioMerieux, Inc. | 02/11/2019SE |
| K173873 | BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic…MDB · Traditional | Becton, Dickinson and Company | 03/16/2018SE |
| 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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| K974578 | Grepafloxacin, 5 MG, Sensi-DiscJTN · Traditional | 02/23/1998SE |
| K970512 | Bactec Myco/F Lytic Culture VialsMDB · Traditional | 01/08/1998SE |
| K972758 | Bactec Myco/F-Sputa Culture VialsMDB · Traditional | 08/08/1997SE |
| K972098 | Fosfomycin, 200 MG, Sensi-DiscJTN · Traditional | 07/28/1997SE |
| K970385 | Sparflozacin, 5 MCG, Sensi-DiscJTN · Traditional | 03/10/1997SE |
| K970212 | Levofloxacin, 5MCG, Sensi-DiscJTN · Traditional | 03/06/1997SE |
Questions and answers
When was Bactec Myco/F Lytic Culture Vials cleared by the FDA?
Bactec Myco/F Lytic Culture Vials (K970333) received a 510(k) decision of Substantially Equivalent on January 28, 1998, 365 days after the submission was received.
What is the product code of K970333?
The FDA product code is MDB – System, Blood Culturing, a Class I (low risk) device regulated under 21 CFR 866.2560.