HTSH RIABEAD DIAGNOSTIC KIT— 510(k) K810381

Name: FDA 510(k) clearance K810381
Creator: U.S. Food and Drug Administration
Published: 1981-02-26

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K810381 for HTSH RIABEAD DIAGNOSTIC KIT, Substantially Equivalent on 1981-02-26. Applicant: Abbott Laboratories. Device class: 1.

Clearance details

Applicant: Abbott Laboratories
Product code: Code CGJ
Device class: Class 1
Regulation: 21 CFR 862.1300
Advisory panel: Clinical Chemistry
Date received: 1981-02-13
Decision date: 1981-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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