OPUS ETHANOL— 510(k) K972011

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K972011 for OPUS ETHANOL, Substantially Equivalent on 1997-07-22. Applicant: Behring Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Behring Diagnostics, Inc.
Product code: Code DIC
Device class: Class 2
Regulation: 21 CFR 862.3040
Advisory panel: Clinical Toxicology
Date received: 1997-05-30
Decision date: 1997-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, 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 Behring Diagnostics, Inc.

K973832 — OPUS HLH CONTROLS1997-10-27
K972929 — N ANTISERUM TO HUMAN ALBUMIN1997-10-20
K972840 — N ANTISERUM TO HUMAN TRANSFERRIN1997-10-17
K973202 — MODIFICATION OF OPUS FERRITIN TEST SYSTEM1997-09-12
K972316 — OPUS D-DIMER1997-09-09

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