MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL
FDA 510(k) K192345 · Liofilchem s.r.l.
510(k) numberK192345
Submission
- Device name
- MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL
- Applicant
- Liofilchem s.r.l.
Roseto Degli Abruzzi, IT - Received
- August 29, 2019
- Decision date
- October 31, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JWY – Manual Antimicrobial Susceptibility Test Systems
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1640
- Specialty
- Microbiology
Other 510(k)s with product code JWY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260447 | ETEST Gepotidacin (GEP) (0.016-256 µg/mL)JWY · Traditional | bioMérieux SA | 04/21/2026SE |
| K260696 | MTS Gepotidacin 0.016-256 µg/mLJWY · Traditional | Liofilchem s.r.l. | 04/17/2026SE |
| K252114 | MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mLJWY · Traditional | Liofilchem s.r.l. | 10/02/2025SE |
| K252062 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the…JWY · Traditional | Thermo Fisher Scientific | 09/25/2025SE |
| K250575 | The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with…JWY · Traditional | Thermo Fisher Scientific | 09/05/2025SE |
| K252014 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the…JWY · Traditional | Thermo Fisher Scientific | 08/28/2025SE |
| K251580 | MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)JWY · Traditional | Liofilchem s.r.l. | 08/20/2025SE |
| K250990 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in…JWY · Traditional | Thermo Fisher Scientific | 06/30/2025SE |
| K242843 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or…JWY · Traditional | Thermo Fisher Scientific | 06/20/2025SE |
| K250856 | ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)JWY · Traditional | Biomérieux | 06/12/2025SE |
More from Biomérieux
| 510(k) | Device | Decision |
|---|---|---|
| K260696 | MTS Gepotidacin 0.016-256 µg/mLJWY · Traditional | 04/17/2026SE |
| K252114 | MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mLJWY · Traditional | 10/02/2025SE |
| K251580 | MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)JWY · Traditional | 08/20/2025SE |
| K243202 | MTS Ceftobiprole 0.002-32 µg/mLJWY · Traditional | 01/30/2025SE |
| K230479 | ComASP Cefiderocol 0.008-128JWY · Traditional | 05/18/2023SE |
| K211672 | MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mLJWY · Traditional | 10/20/2021SE |
| K200180 | MTS Omadacycline 0.002 - 32 ug/mLJWY · Traditional | 03/20/2020SE |
| K191908 | MTS Imipenem 0.016-256 µg/mLJWY · Traditional | 09/04/2019SE |
| K191809 | MTS Imipenem-relebactam 0.002/4-32/4 µg/mLJWY · Traditional | 08/23/2019SE |
| K190914 | MTS Doxycycline 0.016 - 256 µg/mLJWY · Traditional | 05/29/2019SE |
Questions and answers
When was MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL cleared by the FDA?
MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL (K192345) received a 510(k) decision of Substantially Equivalent on October 31, 2019, 63 days after the submission was received.
What is the product code of K192345?
The FDA product code is JWY – Manual Antimicrobial Susceptibility Test Systems, a Class II (moderate risk) device regulated under 21 CFR 866.1640.