CEA DESALTING DOLUMN SEPHADEX R— 510(k) K811394

Name: FDA 510(k) clearance K811394
Creator: U.S. Food and Drug Administration
Published: 1981-06-12

Substantially Equivalent

Immuno-Diagnostic Laboratories

FDA 510(k) clearance K811394 for CEA DESALTING DOLUMN SEPHADEX R, Substantially Equivalent on 1981-06-12. Applicant: Immuno-Diagnostic Laboratories. Device class: 2.

Clearance details

Applicant: Immuno-Diagnostic Laboratories
Product code: Code DHX
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 1981-05-18
Decision date: 1981-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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