ANA-5 AUTOANTIBODY PROFILE KIT— 510(k) K885224

Name: FDA 510(k) clearance K885224
Creator: U.S. Food and Drug Administration
Published: 1989-04-14

Substantially Equivalent

Autoimmunity Diagnostics Corp.

FDA 510(k) clearance K885224 for ANA-5 AUTOANTIBODY PROFILE KIT, Substantially Equivalent on 1989-04-14. Applicant: Autoimmunity Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Autoimmunity Diagnostics Corp.
Product code: Code LKJ
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1988-12-20
Decision date: 1989-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Villa, IL, US

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