ETEST Telavancin (TLA) (0.002-32 ug/mL)
FDA 510(k) K180936 · Biomerieux S.A.
510(k) numberK180936
Submission
- Device name
- ETEST Telavancin (TLA) (0.002-32 ug/mL)
- Applicant
- Biomerieux S.A.
Marcy-L'Etoile, FR - Received
- April 10, 2018
- Decision date
- July 3, 2018
- 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
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| K252114 | MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mLJWY · Traditional | Liofilchem s.r.l. | 10/02/2025SE |
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| 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 |
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| K192738 | ETEST Delafloxacin (DFX) (0.002-32 µg/mL)JWY · Traditional | 11/26/2019SE |
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| K191953 | ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)JWY · Traditional | 08/22/2019SE |
| 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 |
| 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 Telavancin (TLA) (0.002-32 ug/mL) cleared by the FDA?
ETEST Telavancin (TLA) (0.002-32 ug/mL) (K180936) received a 510(k) decision of Substantially Equivalent on July 3, 2018, 84 days after the submission was received.
What is the product code of K180936?
The FDA product code is JWY – Manual Antimicrobial Susceptibility Test Systems, a Class II (moderate risk) device regulated under 21 CFR 866.1640.