TEST, RIA, SERUM DIGOXIN— 510(k) K760077

Name: FDA 510(k) clearance K760077
Creator: U.S. Food and Drug Administration
Published: 1976-07-16

Substantially Equivalent

Smithkline Diagnostics, Inc.

FDA 510(k) clearance K760077 for TEST, RIA, SERUM DIGOXIN, Substantially Equivalent on 1976-07-16. Applicant: Smithkline Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Smithkline Diagnostics, Inc.
Product code: Code DND
Device class: Class 2
Regulation: 21 CFR 862.3300
Advisory panel: Clinical Toxicology
Date received: 1976-06-18
Decision date: 1976-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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