LON — System, Test, Automated, Antimicrobial Susceptibility, Short Incubation Class II
FDA product code LON covers "System, Test, Automated, Antimicrobial Susceptibility, Short Incubation", a Class II medical device regulated under 21 CFR 866.1645. Submissions are reviewed by the Microbiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K260282 | biomerieux | VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance | April 15, 2026 |
| K260281 | biomerieux | VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) | March 26, 2026 |
| 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 |