Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD

K-Number: K232395 · 2023-10-05

ApplicantBiomérieux
Decision Date2023-10-05
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD is a medical device manufactured by Biomérieux. It received FDA 510(k) clearance on 2023-10-05 under approval number K232395. The device is classified under product code JWY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD?

ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD is a medical device that received FDA 510(k) clearance on 2023-10-05. It is manufactured by Biomérieux. The 510(k) number is K232395.

When was ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD approved by the FDA?

ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD received FDA 510(k) clearance on 2023-10-05, under approval number K232395.

What company makes ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD?

ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD is manufactured by Biomérieux.

What is the FDA product code for ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD?

The FDA product code for ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD is JWY.

Other Devices by Biomérieux

K250856ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)

Related Devices (Code: JWY)

K162854Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/mlLiofilchem s.r.l. K161175Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 mcg/mLLiofilchem s.r.l. K153569Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/mlLiofilchem s.r.l. K153687Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mLLiofilchem s.r.l. K173307Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mLLiofilchem s.r.l. K173209Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Meropenem/Vaborbactam in the Dilution Range of 0.008/8 - 18/8 ug/mLThermo Fisher Scientific

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑