TDXR REA(TM) ETHANOL— 510(k) K871645

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K871645 for TDXR REA(TM) ETHANOL, Substantially Equivalent on 1987-06-11. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code DIC
Device class: Class 2
Regulation: 21 CFR 862.3040
Advisory panel: Clinical Toxicology
Date received: 1987-04-28
Decision date: 1987-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DIC

K250609 — Sober Self-Test2025-09-15
K181553 — Immunalysis Ethyl Alcohol Enzyme Assay2018-10-31
K121247 — ALCO-SCREEN2013-03-22
K121256 — ALCO-SCREEN 022012-09-12
K111005 — ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL2011-11-15

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.