STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY— 510(k) K934003

Name: FDA 510(k) clearance K934003
Creator: U.S. Food and Drug Administration
Published: 1994-11-22

Substantially Equivalent

Baxter Diagnostics, Inc.

FDA 510(k) clearance K934003 for STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY, Substantially Equivalent on 1994-11-22. Applicant: Baxter Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Baxter Diagnostics, Inc.
Product code: Code DKA
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1993-08-17
Decision date: 1994-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mcgaw Park, IL, US

Download summary PDF View on FDA.gov ↗

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