BD Phoenix Automated Microbiology System-Meropenem 0.25-16 Ug/Ml
FDA 510(k) K031429 · Bd Diagnostic Systems
510(k) numberK031429
Submission
- Device name
- BD Phoenix Automated Microbiology System-Meropenem 0.25-16 Ug/Ml
- Applicant
- Bd Diagnostic Systems
Sparks, MD, US - Received
- May 6, 2003
- Decision date
- June 6, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LON – System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1645
- Specialty
- Microbiology
Other 510(k)s with product code LON
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260282 | VITEK 2 AST-Streptococcus Inducible Clindamycin ResistanceLON · Traditional | bioMerieux, Inc. | 04/15/2026SE |
| K260281 | VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)LON · Traditional | Biomerieux | 03/26/2026SE |
| K251579 | VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)LON · Traditional | bioMerieux, Inc. | 08/21/2025SE |
| K251713 | BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)LON · Traditional | Becton, Dickinson and Company | 08/08/2025SE |
| K250447 | BD Phoenix Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)LON · Traditional | Becton, Dickinson and Company | 05/19/2025SE |
| K234012 | Vitek Compact ProLON · Traditional | bioMerieux, Inc. | 03/14/2025SE |
| K250344 | BD Phoenix Automated Microbiology SystemLON · Special | Becton, Dickinson and Company | 03/06/2025SE |
| K233986 | BD Phoenix Automated Microbiology System - GN Ciprofloxacin (0.01564 µg/mL)LON · Traditional | Becton, Dickinson and Company | 03/15/2024SE |
| K234000 | VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)LON · Traditional | bioMerieux, Inc. | 03/11/2024SE |
| K232756 | ColibríLON · Traditional | Copan Wasp Srl | 12/27/2023SE |
More from Copan Wasp Srl
| 510(k) | Device | Decision |
|---|---|---|
| K260213 | BD BACTEC FXI Culture SystemMDB · Traditional | 05/28/2026SE |
| K032518 | Pasco Mic and Mic/Id Panels, Gemifloxacin (Strep)JWY · Traditional | 09/15/2003SE |
| K032153 | BD Phoenix Automated Microbiology System Cefotaxime 0.5-64 Ug/MlLON · Traditional | 09/11/2003SE |
| K032259 | Pasco Mic and Mic/Id PanelsJWY · Traditional | 08/19/2003SE |
| K030091 | BD Phoenix Automated Microbiology System - Norfloxacin 0.25 - 16 Ug/MlLON · Traditional | 02/28/2003SE |
Questions and answers
When was BD Phoenix Automated Microbiology System-Meropenem 0.25-16 Ug/Ml cleared by the FDA?
BD Phoenix Automated Microbiology System-Meropenem 0.25-16 Ug/Ml (K031429) received a 510(k) decision of Substantially Equivalent on June 6, 2003, 31 days after the submission was received.
What is the product code of K031429?
The FDA product code is LON – System, Test, Automated, Antimicrobial Susceptibility, Short Incubation, a Class II (moderate risk) device regulated under 21 CFR 866.1645.