TDX METHOTREXATE— 510(k) K830398

Name: FDA 510(k) clearance K830398
Creator: U.S. Food and Drug Administration
Published: 1983-03-10

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K830398 for TDX METHOTREXATE, Substantially Equivalent on 1983-03-10. Applicant: Abbott Laboratories. Device class: Unclassified.

Clearance details

Applicant: Abbott Laboratories
Product code: Code LAO
Device class: Unclassified
Advisory panel: Unknown
Date received: 1983-02-07
Decision date: 1983-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LAO

view all

K233454 — ONLINE TDM Methotrexate2024-02-20
K232017 — ARK Methotrexate II Assay2023-12-20
K163359 — ARK Methotrexate Assay2017-08-18
K111904 — ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN2011-10-18
K932615 — TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II1993-07-14

More clearances from Abbott Laboratories

view all

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.