CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT— 510(k) K871801

Name: FDA 510(k) clearance K871801
Creator: U.S. Food and Drug Administration
Published: 1987-06-09

Substantially Equivalent

Cytotech, Inc.

FDA 510(k) clearance K871801 for CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT, Substantially Equivalent on 1987-06-09. Applicant: Cytotech, Inc.. Device class: 2.

Clearance details

Applicant: Cytotech, Inc.
Product code: Code DHN
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1987-05-08
Decision date: 1987-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.