Meropenem, 10 Mcg, Sensi-Disc

• • Ongoing Z-1033-2024 FDA Class II ·initiated 8 Jan 2024

  There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.

510(k) Number

K963845 ↗

FDA Product Code

JTN

Device Class

Class II

Regulation

21 CFR Part 866.1620

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Gcii Agar with Isovitalx(R) Enrichment

  Class II

  FDA 510(k) K945569 Active Cleared 2 Feb 1995

• Fosfomycin, 200 Mg, Sensi-Disc

  Class II

  FDA 510(k) K972098 Active Cleared 28 Jul 1997

• Enterococcus Screening Medium

  Class II

  FDA 510(k) K951539 Active Cleared 13 Jun 1995

• Sparflozacin, 5 Mcg, Sensi-Disc

  Class II

  FDA 510(k) K970385 Active Cleared 10 Mar 1997

• Crystal Enteric/Nonfermenter Id System

  Class I

  FDA 510(k) K926018 Active Cleared 11 Mar 1993

• Gc II Agar with Isovitalex

  Class II

  FDA 510(k) K932882 Active Cleared 24 Sep 1993

See all devices from Becton Dickinson Microbiology Systems →