DIGOXIN ASSAY FOR THE TECHNICON RA / OPERA SYSTEMS— 510(k) K980521

Name: FDA 510(k) clearance K980521
Creator: U.S. Food and Drug Administration
Published: 1998-04-02

Substantially Equivalent

Bayer Corp.

FDA 510(k) clearance K980521 for DIGOXIN ASSAY FOR THE TECHNICON RA / OPERA SYSTEMS, Substantially Equivalent on 1998-04-02. Applicant: Bayer Corp.. Device class: 2.

Clearance details

Applicant: Bayer Corp.
Product code: Code KXT
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1998-01-28
Decision date: 1998-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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