AXSYM TOBRAMYCIN— 510(k) K941614

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K941614 for AXSYM TOBRAMYCIN, Substantially Equivalent on 1994-08-18. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code LFW
Device class: Class 2
Regulation: 21 CFR 862.3900
Advisory panel: Clinical Toxicology
Date received: 1994-04-04
Decision date: 1994-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LFW

K964670 — ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN1997-02-04
K944371 — TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR1994-11-10
K912143 — CEDIA(R) TOBRAMYCIN ASSAY1991-07-26
K900707 — MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR1990-04-20
K894531 — FPR TOBRAMYCIN KIT1989-09-01

More clearances from Abbott Laboratories

K252424 — Anti-HCV Next2026-04-28
K243500 — ARCHITECT iGentamicin2025-07-09
K243168 — Alinity i Rubella IgG2025-06-20
K243283 — Alinity h-series System2025-02-20
K233932 — Alinity i Toxo IgM2024-08-30

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