BD Phoenix Automated Microbiology System-Ceftriaxone 0.5-64 Ug/Ml
FDA 510(k) K032655 · Becton, Dickinson & CO
510(k) numberK032655
Submission
- Device name
- BD Phoenix Automated Microbiology System-Ceftriaxone 0.5-64 Ug/Ml
- Applicant
- Becton, Dickinson & CO
Sparks, MD, US - Received
- August 28, 2003
- Decision date
- October 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
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|---|---|---|---|
| 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 |
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Questions and answers
When was BD Phoenix Automated Microbiology System-Ceftriaxone 0.5-64 Ug/Ml cleared by the FDA?
BD Phoenix Automated Microbiology System-Ceftriaxone 0.5-64 Ug/Ml (K032655) received a 510(k) decision of Substantially Equivalent on October 6, 2003, 39 days after the submission was received.
What is the product code of K032655?
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.