INNOFLUOR(TM) DIGITOXIN REAGENT SET— 510(k) K913187

Name: FDA 510(k) clearance K913187
Creator: U.S. Food and Drug Administration
Published: 1991-09-23

Substantially Equivalent

Intl. Bioclinical, Inc.

FDA 510(k) clearance K913187 for INNOFLUOR(TM) DIGITOXIN REAGENT SET, Substantially Equivalent on 1991-09-23. Applicant: Intl. Bioclinical, Inc.. Device class: 2.

Clearance details

Applicant: Intl. Bioclinical, Inc.
Product code: Code LFM
Device class: Class 2
Regulation: 21 CFR 862.3300
Advisory panel: Clinical Toxicology
Date received: 1991-07-18
Decision date: 1991-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, OR, US

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