TEST KIT FOR DETECTION OF ANTINUCLEAR— 510(k) K802527

Name: FDA 510(k) clearance K802527
Creator: U.S. Food and Drug Administration
Published: 1981-01-05

Substantially Equivalent

Bartels & Stout, Inc.

FDA 510(k) clearance K802527 for TEST KIT FOR DETECTION OF ANTINUCLEAR, Substantially Equivalent on 1981-01-05. Applicant: Bartels & Stout, Inc.. Device class: 2.

Clearance details

Applicant: Bartels & Stout, Inc.
Product code: Code DHN
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1980-10-15
Decision date: 1981-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellevue, WA, US

Download summary PDF View on FDA.gov ↗

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