REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISK— 510(k) K970830

Name: FDA 510(k) clearance K970830
Creator: U.S. Food and Drug Administration
Published: 1997-04-02

Substantially Equivalent

Remel, Inc.

FDA 510(k) clearance K970830 for REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISK, Substantially Equivalent on 1997-04-02. Applicant: Remel, Inc.. Device class: 2.

Clearance details

Applicant: Remel, Inc.
Product code: Code JTN
Device class: Class 2
Regulation: 21 CFR 866.1620
Advisory panel: Microbiology
Date received: 1997-03-07
Decision date: 1997-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenexa, KS, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JTN

view all

K262113 — HardyDisk AST Tebipenem 10µg (TBP10)2026-08-20
K261781 — Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ602026-07-24
K261853 — Gepotidacin GEP 10 µg2026-07-23
K260842 — HardyDisk AST Gepotidacin 10µg (GEP10)2026-05-11
K251337 — Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP102025-12-05

More clearances from Remel, Inc.

view all

K162620 — Remel Spectra ESBL2017-05-01
K131804 — REMEL XPECT FLU A&B2013-07-12
K092407 — REMEL SPECTRA MRSA2010-10-08
K072827 — RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE2007-11-26
K041951 — XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B2004-11-15

Data sourced from openFDA. This site is unofficial and independent of the FDA.