DIGITOXIN FPIA REAGENT SET— 510(k) K915465

Name: FDA 510(k) clearance K915465
Creator: U.S. Food and Drug Administration
Published: 1992-01-27

Substantially Equivalent

Sigma Diagnostics, Inc.

FDA 510(k) clearance K915465 for DIGITOXIN FPIA REAGENT SET, Substantially Equivalent on 1992-01-27. Applicant: Sigma Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Sigma Diagnostics, Inc.
Product code: Code LFM
Device class: Class 2
Regulation: 21 CFR 862.3300
Advisory panel: Clinical Toxicology
Date received: 1991-12-02
Decision date: 1992-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

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