Product code JWY
- Device name
- Manual Antimicrobial Susceptibility Test Systems
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.1640
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P830028S001 | UNISCEPT(TM) | Analytical Products, Inc. | 1984-03-09 |
| P830028 | UNISCEPT(TM) | Analytical Products, Inc. | 1984-03-01 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260447 | ETEST Gepotidacin (GEP) (0.016-256 µg/mL) | bioMérieux SA | 2026-04-21 |
| K260696 | MTS Gepotidacin 0.016-256 µg/mL | Liofilchem s.r.l. | 2026-04-17 |
| K252114 | MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL | Liofilchem s.r.l. | 2025-10-02 |
| 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 | 2025-09-25 |
| K250575 | The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL | Thermo Fisher Scientific | 2025-09-05 |
| 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 | 2025-08-28 |
| K251580 | MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) | Liofilchem s.r.l. | 2025-08-20 |
| K250990 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL | Thermo Fisher Scientific | 2025-06-30 |
| K242843 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL. | Thermo Fisher Scientific | 2025-06-20 |
| K250856 | ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) | Biomérieux | 2025-06-12 |
| K242659 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL | Thermo Fisher Scientific | 2025-05-22 |
| K250274 | ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) | Biomerieux S.A. | 2025-04-30 |
| K242658 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL | Thermo Fisher Scientific | 2025-04-15 |
| K243201 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 ug/mL | Thermo Fisher Scientific | 2025-02-10 |
| K242905 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.12-32 ug/mL | Thermo Fisher Scientific | 2025-02-10 |
| K243202 | MTS Ceftobiprole 0.002-32 µg/mL | Liofilchem s.r.l. | 2025-01-30 |
| K243169 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL | Thermo Fisher Scientific | 2024-12-19 |
| 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 | 2024-12-05 |
| 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 | 2024-11-26 |
| K242021 | The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Meropenem in the dilution range of 0.015 - 32 ug/ml. | Thermo Fisher Scientific | 2024-10-09 |
| K241967 | The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with ceftriaxone in the dilution range of 0.015 - 2 ug/ml. | Thermo Fisher Scientific | 2024-10-01 |
| K240445 | The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Imipenem in the dilution range of 0.015 - 4 ug/ml. | Thermo Fisher Scientific | 2024-05-16 |
| K232310 | Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftolozane-tazobactam in the dilution range of 0.03/4-64/4ug/ml | Thermo Fisher Scientific | 2023-10-31 |
| K232395 | ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD | Biomérieux | 2023-10-05 |
| K231988 | Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2µg/ml | Thermo Fisher Scientific | 2023-08-30 |
| K231994 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mL | Thermo Fisher Scientific | 2023-08-25 |
| K230935 | Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae) | Thermo Fisher Scientific | 2023-06-30 |
| K230479 | ComASP Cefiderocol 0.008-128 | Liofilchem s.r.l. | 2023-05-18 |
| K223844 | Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8ug/ml (Streptococcus species) and 0.000125-8ug/ml (Haemophilus influenzae) | Thermo Fisher Scientific | 2023-03-21 |
| 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 | 2021-12-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08055182871162 | Liofilchem Mic Test Strip (MTS) | LIOFILCHEM SRL | 2019-12-06 |
| 08055182871155 | Liofilchem Mic Test Strip (MTS) | LIOFILCHEM SRL | 2019-12-06 |
| 08055182870622 | Liofilchem MIC Test Strip | LIOFILCHEM SRL | 2019-08-02 |
| 08055182870615 | Liofilchem MIC Test Strip | LIOFILCHEM SRL | 2019-08-02 |
| 08055182871704 | Liofilchem Mic Test Strip (MTS) | LIOFILCHEM SRL | 2019-04-19 |
| 08055182871698 | Liofilchem Mic Test Strip (MTS) | LIOFILCHEM SRL | 2019-04-19 |
| 08055182871254 | Liofilchem MIC Test Strip | LIOFILCHEM SRL | 2018-06-08 |
| 08055182871247 | Liofilchem MIC Test Strip (MTS) | LIOFILCHEM SRL | 2018-06-08 |
| 08055182870318 | Liofilchem MIC Test Strip (MTS) | LIOFILCHEM SRL | 2018-01-10 |
| 08055182870325 | Liofilchem MIC Test Strip (MTS) | LIOFILCHEM SRL | 2018-01-10 |
| 08055182870288 | Liofilchem MIC Test Strip (MTS) | LIOFILCHEM SRL | 2017-11-06 |
| 08055182870295 | Liofilchem MIC Test Strip (MTS) | LIOFILCHEM SRL | 2017-11-06 |
| 08055182870257 | Liofilchem MIC Test Strip (MTS) | LIOFILCHEM SRL | 2017-09-13 |
| 08055182870264 | Liofilchem MIC Test Strip (MTS) | LIOFILCHEM SRL | 2017-09-13 |
| 08055182870172 | Liofilchem MIC Test Strip (MTS) | LIOFILCHEM SRL | 2017-07-12 |
| 08055182870165 | Liofilchem MIC Test Strip (MTS) | LIOFILCHEM SRL | 2017-07-12 |
| 08055182870141 | Liofilchem MIC Test Strip (MTS) | LIOFILCHEM SRL | 2017-07-12 |
| 08055182870134 | Liofilchem MIC Test Strip (MTS) | LIOFILCHEM SRL | 2017-07-12 |
| 08055182870233 | Liofilchem MIC Test Strip (MTS) | LIOFILCHEM SRL | 2017-04-12 |
| 08055182870226 | Liofilchem MIC Test Strip (MTS) | LIOFILCHEM SRL | 2017-04-12 |
| 08055182870202 | Liofilchem MIC Test Strip (MTS) | LIOFILCHEM SRL | 2017-03-06 |
| 08055182870196 | Liofilchem MIC Test Strip (MTS) | LIOFILCHEM SRL | 2017-03-06 |
| 08055182870011 | Liofilchem MIC Test Strip (MTS) | LIOFILCHEM SRL | 2017-01-31 |
| 08055182870110 | Liofilchem MIC Test Strip (MTS) | LIOFILCHEM SRL | 2017-01-31 |
| 08055182870103 | Liofilchem MIC Test Strip (MTS) | LIOFILCHEM SRL | 2017-01-31 |
| 08055182870028 | Liofilchem MIC Test Strip (MTS) | LIOFILCHEM SRL | 2017-01-31 |
| 08055182870080 | Liofilchem MIC Test Strip (MTS) | LIOFILCHEM SRL | 2017-01-20 |
| 08055182870073 | Liofilchem MIC Test Strip (MTS) | LIOFILCHEM SRL | 2017-01-20 |
| 08055182870059 | Liofilchem MIC Test Strip (MTS) | LIOFILCHEM SRL | 2017-01-20 |
| 08055182870042 | Liofilchem MIC Test Strip (MTS) | LIOFILCHEM SRL | 2017-01-20 |