AZTREONAM 30 MCG SENSITIVITY DISKS— 510(k) K870347

Name: FDA 510(k) clearance K870347
Creator: U.S. Food and Drug Administration
Published: 1987-03-05

Substantially Equivalent

Difco Laboratories, Inc.

FDA 510(k) clearance K870347 for AZTREONAM 30 MCG SENSITIVITY DISKS, Substantially Equivalent on 1987-03-05. Applicant: Difco Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Difco Laboratories, Inc.
Product code: Code JTN
Device class: Class 2
Regulation: 21 CFR 866.1620
Advisory panel: Microbiology
Date received: 1987-01-28
Decision date: 1987-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Detroit, MI, 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 Difco Laboratories, Inc.

view all

K971120 — DISPENS-O-DISC (TM) LEVOFLOXACIN1997-04-14
K971211 — DISPENS-O-DISC SPARFLOXACIN1997-04-14
K963508 — DISPENS-O-DISC MEROPENEM1996-09-26
K961148 — CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG)1996-04-26
K954783 — DRYSLIDE CARTARRHALIS1996-02-06

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