JWY — Manual Antimicrobial Susceptibility Test Systems Class II
FDA Device Classification
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 |
|---|
| K252114 | liofilchem s. r. l | 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 s. r. l | 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 s. r. l | 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 |
| K241967 | thermo fisher scientific | The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) | October 1, 2024 |
| K240445 | thermo fisher scientific | The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) | May 16, 2024 |