JWY
- Product code
- JWY
- Device name
- Manual Antimicrobial Susceptibility Test Systems
- Device class
- Class 2
- 21 CFR
- 21 CFR 866.1640
- Medical specialty
- Microbiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 24
- Summaries archived here
- 7 (direct download)
- 510(k) clearances (all years, FDA)
- 441 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (24)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260447 | 2026-04-21 | bioMérieux SA | ETEST Gepotidacin (GEP) (0.016-256 µg/mL) | |
| K260696 | 2026-04-17 | Liofilchem s.r.l. | MTS Gepotidacin 0.016-256 µg/mL | |
| K252114 | 2025-10-02 | Liofilchem s.r.l. | MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL | |
| K252062 | 2025-09-25 | Thermo Fisher Scientific | The Sensititre 18-24 hour MIC or Breakpoint Suscepti… | — |
| K250575 | 2025-09-05 | Thermo Fisher Scientific | The Sensititre 18 - 24 hour MIC or Breakpoint Suscep… | — |
| K252014 | 2025-08-28 | Thermo Fisher Scientific | The Sensititre 18-24 hour MIC or Breakpoint Suscepti… | — |
| K251580 | 2025-08-20 | Liofilchem s.r.l. | MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD… | |
| K250990 | 2025-06-30 | Thermo Fisher Scientific | The Sensititre 18-24 hour MIC or Breakpoint Suscepti… | — |
| K242843 | 2025-06-20 | Thermo Fisher Scientific | The Sensititre 20-24 hour Haemophilus influenzae/Str… | — |
| K250856 | 2025-06-12 | Biomérieux | ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL… | |
| K242659 | 2025-05-22 | Thermo Fisher Scientific | The Sensititre 18-24 hour MIC or Breakpoint Suscepti… | — |
| K250274 | 2025-04-30 | Biomerieux S.A. | ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.00… | |
| K242658 | 2025-04-15 | Thermo Fisher Scientific | The Sensititre 18-24 hour MIC or Breakpoint Suscepti… | — |
| K243201 | 2025-02-10 | Thermo Fisher Scientific | The Sensititre 20-24 hour Haemophilus influenzae/Str… | — |
| K242905 | 2025-02-10 | Thermo Fisher Scientific | The Sensititre 20-24 hour Haemophilus influenzae/Str… | — |
| K243202 | 2025-01-30 | Liofilchem s.r.l. | MTS Ceftobiprole 0.002-32 µg/mL | — |
| K243169 | 2024-12-19 | Thermo Fisher Scientific | The Sensititre 18-24 hour MIC or Breakpoint Suscepti… | — |
| K242653 | 2024-12-05 | Thermo Fisher Scientific | The Sensititre 18-24 hour MIC or Breakpoint Suscepti… | — |
| K242657 | 2024-11-26 | Thermo Fisher Scientific | The Sensititre 18-24 hour MIC or Breakpoint Suscepti… | — |
| K242021 | 2024-10-09 | Thermo Fisher Scientific | The Sensititre 20 - 24 hour Haemophilus influenzae/S… | — |
| K241967 | 2024-10-01 | Thermo Fisher Scientific | The Sensititre 20 - 24 hour Haemophilus influenzae/S… | — |
| K240445 | 2024-05-16 | Thermo Fisher Scientific | The Sensititre 20 - 24 hour Haemophilus influenzae/S… | — |
| K232310 | 2023-10-31 | Thermo Fisher Scientific | Sensititre 20-24 hour Haemophilus influenzaelStrepto… | — |
| K232395 | 2023-10-05 | Biomérieux | ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/… |
Official FDA classification page: JWY
Classification and pathway per current FDA publications. Data from openFDA (CC0).