LON — System, Test, Automated, Antimicrobial Susceptibility, Short Incubation Class II
FDA Device Classification
Classification Details
- Product Code
- LON
- Device Class
- Class II
- Regulation Number
- 866.1645
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K251579 | biomerieux | VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) | August 21, 2025 |
| K251713 | becton, dickinson and | BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) | August 8, 2025 |
| K250447 | becton, dickinson and | BD Phoenix Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 1 | May 19, 2025 |
| K234012 | biomerieux | VITEK COMPACT PRO | March 14, 2025 |
| K250344 | becton, dickinson and | BD Phoenix Automated Microbiology System | March 6, 2025 |
| K233986 | becton, dickinson and | BD Phoenix Automated Microbiology System - GN Ciprofloxacin (0.01564 µg/mL) | March 15, 2024 |
| K234000 | biomerieux | VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) | March 11, 2024 |
| K232756 | copan wasp | Colibrí | December 27, 2023 |
| K232201 | biomerieux | VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus | October 23, 2023 |
| K230864 | biomerieux | VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptom | July 5, 2023 |
| K222378 | biomerieux | VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL) | June 26, 2023 |
| K211748 | selux diagnostics | Selux AST System; Model AST Gen 1.0 | April 19, 2023 |
| K222430 | biomerieux sa | VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomy | March 9, 2023 |
| K223478 | biomerieux | VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazo | February 16, 2023 |
| K222073 | biomerieux | VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL) | February 9, 2023 |
| K223481 | biomerieux | VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL) | February 3, 2023 |
| K220803 | biomerieux | VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifl | January 27, 2023 |
| K211759 | selux diagnostics | Selux AST System; Model AST Gen 1.0 | January 18, 2023 |
| K220805 | biomerieux | VITEK 2 AST-Gram Positive Cefoxitin Screen | October 13, 2022 |
| K220546 | copan wasp | Colibrí System | October 5, 2022 |