ANTINUCLEAR ANTIBODY TEST KIT— 510(k) K851369

Name: FDA 510(k) clearance K851369
Creator: U.S. Food and Drug Administration
Published: 1985-05-15

Substantially Equivalent

Modern Diagnostics, Inc.

FDA 510(k) clearance K851369 for ANTINUCLEAR ANTIBODY TEST KIT, Substantially Equivalent on 1985-05-15. Applicant: Modern Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Modern Diagnostics, Inc.
Product code: Code DHN
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1985-04-05
Decision date: 1985-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sacramento, CA, US

Download summary PDF View on FDA.gov ↗

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