Panels › Microbiology › Product code JWY · Class 2
Manual Antimicrobial Susceptibility Test Systems
Regulation 866.1640
2510(k)s in 12 months (441 all time)
0recalls in 12 months (78 all time)
77recalls that name a 510(k)
Top companies in JWY
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 21, 2026 | K260447 | ETEST Gepotidacin (GEP) (0.016-256 µg/mL) bioMérieux SA, FR | JWY |
| Apr 17, 2026 | K260696 | MTS Gepotidacin 0.016-256 µg/mL Liofilchem s.r.l., IT | JWY |
| Oct 2, 2025 | K252114 | MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL Liofilchem s.r.l., IT | JWY |
| Sep 25, 2025 | K252062 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL Thermo Fisher Scientific | JWY |
| Sep 5, 2025 | K250575 | The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0. Thermo Fisher Scientific | JWY |
| Aug 28, 2025 | K252014 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL Thermo Fisher Scientific | JWY |
| Aug 20, 2025 | K251580 | MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) Liofilchem s.r.l., IT | JWY |
| Jun 30, 2025 | K250990 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 u Thermo Fisher Scientific | JWY |
| Jun 20, 2025 | K242843 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System w Thermo Fisher Scientific | JWY |
| Jun 12, 2025 | K250856 | ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) Biomérieux, FR | JWY |
| May 22, 2025 | K242659 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/m Thermo Fisher Scientific | JWY |
| Apr 30, 2025 | K250274 | ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) Biomerieux S.A., FR | JWY |
| Apr 15, 2025 | K242658 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug Thermo Fisher Scientific | JWY |
| Feb 10, 2025 | K243201 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System w Thermo Fisher Scientific | JWY |
| Feb 10, 2025 | K242905 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System w Thermo Fisher Scientific | JWY |
| Jan 30, 2025 | K243202 | MTS Ceftobiprole 0.002-32 µg/mL Liofilchem s.r.l., IT | JWY |
| Dec 19, 2024 | K243169 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug Thermo Fisher Scientific | JWY |
| Dec 5, 2024 | K242653 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.25-32 ug/mL Thermo Fisher Scientific | JWY |
| Nov 26, 2024 | K242657 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Daptomycin in the dilution range of 0.03-64 ug/mL Thermo Fisher Scientific | JWY |
| Oct 9, 2024 | K242021 | The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System Thermo Fisher Scientific | JWY |
| Oct 1, 2024 | K241967 | The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System Thermo Fisher Scientific | JWY |
| May 16, 2024 | K240445 | The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System Thermo Fisher Scientific | JWY |
| Oct 31, 2023 | K232310 | Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibility System with Cefto Thermo Fisher Scientific | JWY |
| Oct 5, 2023 | K232395 | ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD Biomérieux, FR | JWY |
| Aug 30, 2023 | K231988 | Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalba Thermo Fisher Scientific | JWY |
| Aug 25, 2023 | K231994 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/ Thermo Fisher Scientific | JWY |
| Jun 30, 2023 | K230935 | Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imip Thermo Fisher Scientific | JWY |
| May 18, 2023 | K230479 | ComASP Cefiderocol 0.008-128 Liofilchem s.r.l., IT | JWY |
| Mar 21, 2023 | K223844 | Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delaf Thermo Fisher Scientific | JWY |
| Dec 20, 2021 | K203741 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml Thermo Fisher Scientific | JWY |
| Nov 12, 2021 | K210757 | ETEST Fosfomycin (FO) (0.032-512 µg/mL) Biomerieux S.A., FR | JWY |
| Oct 20, 2021 | K211672 | MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL Liofilchem s.r.l., IT | JWY |
| Jul 23, 2021 | K202612 | Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dtes Thermo Fisher Scientific | JWY |
| May 18, 2021 | K202423 | MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL) Beckman Coulter, Inc. | JWY |
| May 7, 2020 | K200512 | ETEST Plazomicin (PLZ) (0.016-256 µg/mL) Biomérieux SA, FR | JWY |
| Apr 6, 2020 | K200308 | MTS Lefamulin 0.016- 256 µg/mL Liofilchem S. R. 1., IT | JWY |
| Mar 20, 2020 | K200180 | MTS Omadacycline 0.002 - 32 ug/mL Liofilchem s.r.l., IT | JWY |
| Mar 12, 2020 | K193538 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 µg/ml Thermo Fisher Scientific | JWY |
| Jan 8, 2020 | K193024 | Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefa Thermo Fisher Scientific | JWY |
| Nov 26, 2019 | K192738 | ETEST Delafloxacin (DFX) (0.002-32 µg/mL) Biomerieux S.A., FR | JWY |
| Nov 14, 2019 | K192355 | MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL) Beckman Coulter, Inc. | JWY |
| Nov 6, 2019 | K192729 | Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/ml Thermo Fisher Scientific | JWY |
| Oct 31, 2019 | K192345 | MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL Liofilchem s.r.l., IT | JWY |
| Oct 16, 2019 | K192250 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 0.03/4-2 Thermo Fisher Scientific | JWY |
| Sep 27, 2019 | K192050 | ETEST Eravacycline (ERV) (0.002 32 µg/mL) Biomerieux S.A., FR | JWY |
| Sep 4, 2019 | K191908 | MTS Imipenem 0.016-256 µg/mL Liofilchem s.r.l., IT | JWY |
| Aug 23, 2019 | K191809 | MTS Imipenem-relebactam 0.002/4-32/4 µg/mL Liofilchem s.r.l., IT | JWY |
| Aug 22, 2019 | K191953 | ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) Biomerieux S.A., FR | JWY |
| May 29, 2019 | K190914 | MTS Doxycycline 0.016 - 256 µg/mL Liofilchem s.r.l., IT | JWY |
| May 1, 2019 | K190154 | ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL) Biomerieux S.A., FR | JWY |
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