JWY — Manual Antimicrobial Susceptibility Test Systems Class II
FDA product code JWY covers "Manual Antimicrobial Susceptibility Test Systems", a Class II medical device regulated under 21 CFR 866.1640. 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
- JWY
- Device Class
- Class II
- Regulation Number
- 866.1640
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260447 | biomérieux | ETEST Gepotidacin (GEP) (0.016-256 µg/mL) | April 21, 2026 |
| K260696 | liofilchem | MTS Gepotidacin 0.016-256 µg/mL | April 17, 2026 |
| K252114 | liofilchem | MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL | October 2, 2025 |
| K252062 | thermo fisher scientific | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin | September 25, 2025 |
| K250575 | thermo fisher scientific | The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreon | September 5, 2025 |
| K252014 | thermo fisher scientific | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin | August 28, 2025 |
| K251580 | liofilchem | MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) | August 20, 2025 |
| K250990 | thermo fisher scientific | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciproflox | June 30, 2025 |
| K242843 | thermo fisher scientific | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) M | June 20, 2025 |
| K250856 | biomérieux | ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) | June 12, 2025 |
| K242659 | thermo fisher scientific | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomyci | May 22, 2025 |
| K250274 | biomerieux | ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) | April 30, 2025 |
| K242658 | thermo fisher scientific | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxa | April 15, 2025 |
| K243201 | thermo fisher scientific | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) M | February 10, 2025 |
| K242905 | thermo fisher scientific | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) M | February 10, 2025 |
| K243202 | liofilchem | MTS Ceftobiprole 0.002-32 µg/mL | January 30, 2025 |
| K243169 | thermo fisher scientific | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobipr | December 19, 2024 |
| K242653 | thermo fisher scientific | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid | December 5, 2024 |
| K242657 | thermo fisher scientific | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Daptomyci | November 26, 2024 |
| K242021 | thermo fisher scientific | The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) | October 9, 2024 |