DIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS— 510(k) K951631

Name: FDA 510(k) clearance K951631
Creator: U.S. Food and Drug Administration
Published: 1995-06-09

Substantially Equivalent

Bayer Corp.

FDA 510(k) clearance K951631 for DIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS, Substantially Equivalent on 1995-06-09. Applicant: Bayer Corp.. Device class: 2.

Clearance details

Applicant: Bayer Corp.
Product code: Code LFM
Device class: Class 2
Regulation: 21 CFR 862.3300
Advisory panel: Clinical Toxicology
Date received: 1995-04-07
Decision date: 1995-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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