ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)
FDA 510(k) K191953 · Biomerieux S.A.
510(k) numberK191953
Submission
- Device name
- ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)
- Applicant
- Biomerieux S.A.
Marcy-L'Etoile, FR - Received
- July 22, 2019
- Decision date
- August 22, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K250274 | ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)JWY · Traditional | 04/30/2025SE |
| K210757 | ETEST Fosfomycin (FO) (0.032-512 µg/mL)JWY · Traditional | 11/12/2021SE |
| K192738 | ETEST Delafloxacin (DFX) (0.002-32 µg/mL)JWY · Traditional | 11/26/2019SE |
| K192050 | ETEST Eravacycline (ERV) (0.002 32 µg/mL)JWY · Traditional | 09/27/2019SE |
| K190154 | ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)JWY · Traditional | 05/01/2019SE |
| K183031 | ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)JWY · Traditional | 01/11/2019SE |
| K181092 | CHROMID CARBA agar (CARB)JSO · Traditional | 07/06/2018SE |
| K180936 | ETEST Telavancin (TLA) (0.002-32 ug/mL)JWY · Traditional | 07/03/2018SE |
| K162385 | Rapidec Carba NPPTJ · Traditional | 04/27/2017SE |
| K151873 | Etest Ceftaroline (0.002 - 32ug/ml)JWY · Traditional | 10/07/2015SE |
Questions and answers
When was ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) cleared by the FDA?
ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) (K191953) received a 510(k) decision of Substantially Equivalent on August 22, 2019, 31 days after the submission was received.
What is the product code of K191953?
The FDA product code is JWY – Manual Antimicrobial Susceptibility Test Systems, a Class II (moderate risk) device regulated under 21 CFR 866.1640.