125I-ALDOSTERONE RIA DIAG. KIT— 510(k) K781504

Name: FDA 510(k) clearance K781504
Creator: U.S. Food and Drug Administration
Published: 1978-11-22

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K781504 for 125I-ALDOSTERONE RIA DIAG. KIT, Substantially Equivalent on 1978-11-22. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code CJM
Device class: Class 2
Regulation: 21 CFR 862.1045
Advisory panel: Clinical Chemistry
Date received: 1978-08-30
Decision date: 1978-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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