FDA 510(k)

ETEST Gepotidacin (GEP) (0.016-256 µg/mL)

K-Number: K260447 · 2026-04-21

Decision Date2026-04-21

Product CodeJWY

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

ETEST Gepotidacin (GEP) (0.016-256 µg/mL) is the device name listed in this FDA 510(k) record. The listed applicant is bioMérieux SA. It received FDA 510(k) clearance on 2026-04-21 under 510(k) number K260447. 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 Gepotidacin (GEP) (0.016-256 µg/mL)?

ETEST Gepotidacin (GEP) (0.016-256 µg/mL) is a medical device that received FDA 510(k) clearance on 2026-04-21. The listed applicant is bioMérieux SA. The 510(k) number is K260447.

When did ETEST Gepotidacin (GEP) (0.016-256 µg/mL) receive FDA 510(k) clearance?

ETEST Gepotidacin (GEP) (0.016-256 µg/mL) received FDA 510(k) clearance on 2026-04-21, under 510(k) number K260447.

Who is the listed applicant for ETEST Gepotidacin (GEP) (0.016-256 µg/mL)?

The FDA 510(k) record lists bioMérieux SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ETEST Gepotidacin (GEP) (0.016-256 µg/mL)?

The FDA product code for ETEST Gepotidacin (GEP) (0.016-256 µg/mL) is JWY.

Other records listing bioMérieux SA as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250856ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)K232395ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD K210793VIDAS NEPHROCHECK K212849VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)K200512ETEST Plazomicin (PLZ) (0.016-256 µg/mL)

Related Devices (Code: JWY)

K260696MTS Gepotidacin 0.016-256 µg/mLLiofilchem s.r.l.K252114MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mLLiofilchem s.r.l.K252062The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mLThermo Fisher Scientific K250575The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mLThermo Fisher Scientific K252014The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mLThermo Fisher Scientific K251580MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)Liofilchem s.r.l.

Official Source

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