DIGOXIN CLASP RIA KIT— 510(k) K800997

Name: FDA 510(k) clearance K800997
Creator: U.S. Food and Drug Administration
Published: 1980-05-08

Substantially Equivalent

E. R. Squibb & Sons, Inc.

FDA 510(k) clearance K800997 for DIGOXIN CLASP RIA KIT, Substantially Equivalent on 1980-05-08. Applicant: E. R. Squibb & Sons, Inc.. Device class: 2.

Clearance details

Applicant: E. R. Squibb & Sons, Inc.
Product code: Code LCS
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1980-04-25
Decision date: 1980-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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