FDA 510(k)

ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)

K-Number: K191953 · 2019-08-22

Decision Date2019-08-22

Product CodeJWY

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) is the device name listed in this FDA 510(k) record. The listed applicant is Biomerieux S.A.. It received FDA 510(k) clearance on 2019-08-22 under 510(k) number K191953. 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 Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)?

ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) is a medical device that received FDA 510(k) clearance on 2019-08-22. The listed applicant is Biomerieux S.A.. The 510(k) number is K191953.

When did ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) receive FDA 510(k) clearance?

ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) received FDA 510(k) clearance on 2019-08-22, under 510(k) number K191953.

Who is the listed applicant for ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)?

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

What is the FDA product code for ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)?

The FDA product code for ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) is JWY.

Other records listing Biomerieux S.A. 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.

K250274ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)K210757ETEST Fosfomycin (FO) (0.032-512 µg/mL)K192738ETEST Delafloxacin (DFX) (0.002-32 µg/mL)K192050ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)K190154ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)K183031ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)

View all 10 devices →

Related Devices (Code: JWY)

K260447ETEST Gepotidacin (GEP) (0.016-256 µg/mL)bioMérieux SA 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

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.