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510(k) K191953

ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) by Biomerieux S.A. — Product Code JWY

K191953 is an FDA 510(k) premarket notification submitted by Biomerieux S.A. for the device "ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)". The FDA issued a decision of Substantially Equivalent on Aug 22, 2019. The device falls under product code JWY (Manual Antimicrobial Susceptibility Test Systems), a Class II device regulated under 21 CFR 866.1640. Biomerieux S.A. has 270 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 22, 2019
Date Received
Jul 22, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Manual Antimicrobial Susceptibility Test Systems
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type
510(k)

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Other clearances for product code JWY

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  • K250575 — The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with… (Sep 5, 2025)
  • K252014 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin… (Aug 28, 2025)
  • K251580 — MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) (Aug 20, 2025)
  • K250990 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with… (Jun 30, 2025)
  • K242843 — The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP)… (Jun 20, 2025)
  • K250856 — ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) (Jun 12, 2025)

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