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 18, 2019 | K190109 | MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL) Beckman Coulter, Inc. | JWY |
| Mar 22, 2019 | K190252 | MTS Gentamicin 0.016 - 256 µg/mL Liofilchem s.r.l., IT | JWY |
| Mar 19, 2019 | K183527 | MTS Ciprofloxacin 0.002 - 32 µg/mL Liofilchem s.r.l., IT | JWY |
| Feb 15, 2019 | K183324 | Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omada Thermo Fisher Scientific | JWY |
| Jan 11, 2019 | K183140 | MTS Tetracycline 0.016 - 256 ug/mL Liofilchem s.r.l., IT | JWY |
| Jan 11, 2019 | K183031 | ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL) Biomerieux S.A., FR | JWY |
| Jan 4, 2019 | K183033 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml Thermo Fisher Scientific | JWY |
| Dec 20, 2018 | K183115 | MTS Levofloxacin 0.002 - 32 µg/mL Liofilchem s.r.l., IT | JWY |
| Dec 14, 2018 | K182922 | MTS Omadacycline 0.002-32 µg/mL Liofilchem s.r.l., IT | JWY |
| Nov 30, 2018 | K182797 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Eravacycline in the dilution range of 0.008- 16 µg/mL Thermo Fisher Scientific | JWY |
| Nov 2, 2018 | K182557 | MTS Eravacycline 0.002 - 32 µg/mL Liofilchem s.r.l., IT | JWY |
| Sep 13, 2018 | K181889 | MTS Penicillin 0.002- 32 µg/mL Liofilchem s.r.l., IT | JWY |
| Aug 8, 2018 | K181946 | Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL Thermo Fisher Scientific | JWY |
| Jul 31, 2018 | K181708 | MTS Plazomicin 0.016-256 µg/mL Liofilchem s.r.l., IT | JWY |
| Jul 3, 2018 | K180936 | ETEST Telavancin (TLA) (0.002-32 ug/mL) Biomerieux S.A., FR | JWY |
| May 18, 2018 | K180886 | Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL Liofilchem s.r.l., IT | JWY |
| Apr 4, 2018 | K180339 | Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 µg/mL Liofilchem s.r.l., IT | JWY |
| Mar 15, 2018 | K180330 | Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL Liofilchem s.r.l., IT | JWY |
| Feb 28, 2018 | K173817 | Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 µg/mL Liofilchem s.r.l., IT | JWY |
| Dec 19, 2017 | K173307 | Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mL Liofilchem s.r.l., IT | JWY |
| Dec 1, 2017 | K173209 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Meropenem/Vaborbactam in the Dilution Range of 0.008/ Thermo Fisher Scientific | JWY |
| Oct 23, 2017 | K172542 | Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 mg/mL. Liofilchem s.r.l., IT | JWY |
| Oct 13, 2017 | K172454 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.004-8 ug/mL Thermo Fisher Scientific | JWY |
| Sep 27, 2017 | K172109 | Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 µg/mL Liofilchem s.r.l., IT | JWY |
| Sep 15, 2017 | K172150 | Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL) bioMerieux, Inc. | JWY |
| Aug 30, 2017 | K172274 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with D Thermo Fisher Scientific | JWY |
| Aug 1, 2017 | K171906 | Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 µg/mL Liofilchem s.r.l., IT | JWY |
| Aug 1, 2017 | K171870 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.0005 8 Thermo Fisher Scientific | JWY |
| Jun 7, 2017 | K170772 | Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 µg/mL Liofilchem s.r.l., IT | JWY |
| May 31, 2017 | K170670 | Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml) bioMerieux, Inc. | JWY |
| May 25, 2017 | K170892 | Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 µg/mL Liofilchem s.r.l., IT | JWY |
| Mar 14, 2017 | K163517 | Liofilchem MIC Test Strip (MTS) Telavancin 0.016 - 256.0 µg/mL Liofilchem s.r.l., IT | JWY |
| Feb 22, 2017 | K163298 | Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 µg/mL Liofilchem s.r.l., IT | JWY |
| Dec 19, 2016 | K162854 | Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml Liofilchem s.r.l., IT | JWY |
| Jul 12, 2016 | K161175 | Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 mcg/mL Liofilchem s.r.l., IT | JWY |
| Jun 22, 2016 | K153569 | Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml Liofilchem s.r.l., IT | JWY |
| Mar 31, 2016 | K153687 | Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL Liofilchem s.r.l., IT | JWY |
| Dec 21, 2015 | K152774 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftazidime/Avibactam in the dilutions range of 0 Thermo Fisher Scientific | JWY |
| Oct 7, 2015 | K151873 | Etest Ceftaroline (0.002 - 32ug/ml) Biomerieux S.A., FR | JWY |
| Sep 16, 2015 | K152346 | MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL) Beckman Coulter, Inc. | JWY |
| Aug 28, 2015 | K150556 | Sensititre 18-24 hours MIC or BP Susceptibility System with Ceftolozane/tazobactam (0.03/4- 64/4ug/mL) Thermo Fisher Scientific | JWY |
| Jul 27, 2015 | K150236 | Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Dalbavancin (0.0005 - 2ug/mL) Thermo Fisher Scientific | JWY |
| Apr 1, 2015 | K143288 | Sensititre Susceptibility plates Thermo Fisher Scientific | JWY |
| Mar 5, 2015 | K143526 | The Sensititre HP MIC Susceptibility plate with Oritavancin (0.0005-8mcg/ml) Thermo Fisher Scientific | JWY |
| Mar 2, 2015 | K142338 | Sensititre HP MIC Susceptibility Plate with Tedizolid (0.002-4 mcg/ml) Thermo Fisher Scientific | JWY |
| Feb 19, 2015 | K143381 | Sensititre Susceptibility Plates Thermo Fisher Scientific | JWY |
| Dec 23, 2014 | K142151 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES Thermo Fisher Scientific | JWY |
| Oct 21, 2014 | K141651 | SENSITITRE SUSCEPTIBILITY PLATES Thermo Fisher Scientific | JWY |
| Aug 1, 2014 | K133847 | SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) SUSCEPTIBILITY PLATES Thermo Fisher Scientific | JWY |
| Jul 16, 2014 | K141000 | SENSITITRE SUSCEPTIBILITY PLATES Thermo Fisher Scientific | JWY |
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