Cleared Traditional

GREPAFLOXACIN, 5 MG, SENSI-DISC

K974578 · Becton Dickinson Microbiology Systems · Microbiology
Feb 1998
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K974578 is an FDA 510(k) clearance for the GREPAFLOXACIN, 5 MG, SENSI-DISC, a Susceptibility Test Discs, Antimicrobial (Class II — Special Controls, product code JTN), submitted by Becton Dickinson Microbiology Systems (Sparks, US). The FDA issued a Cleared decision on February 23, 1998, 77 days after receiving the submission on December 8, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1620.

Submission Details

510(k) Number K974578 FDA.gov
FDA Decision Cleared SESE
Date Received December 08, 1997
Decision Date February 23, 1998
Days to Decision 77 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code JTN — Susceptibility Test Discs, Antimicrobial
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1620

Similar Devices — JTN Susceptibility Test Discs, Antimicrobial

All 326
Thermo Scientific Oxoid Gepotidacin Disc (10 ?g) GEP10
K251337 · Thermo Fisher Scientific (Oxoid Ltd.) · Dec 2025
HardyDisk AST Cefiderocol 30?g (FDC30)
K253105 · Hardy Diagnostics · Nov 2025
Sulopenem SPM 2 ?g
K251879 · Liofilchem · Aug 2025
HardyDisk AST Gepotidacin 10?g (GEP10)
K250956 · Hardy Diagnostics · Jun 2025
Ceftobiprole BPR 5 ?g Disc
K250885 · Liofilchem, Inc. · Jun 2025
Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 ?g) AZA50
K250789 · Thermo Fisher Scientific (Oxoid Ltd.) · Jun 2025