THYROGLOBULIN AUTO-ANTIBODY EIA TEST KIT— 510(k) K925194

Name: FDA 510(k) clearance K925194
Creator: U.S. Food and Drug Administration
Published: 1993-02-05

Substantially Equivalent

Joldon Diagnostics

FDA 510(k) clearance K925194 for THYROGLOBULIN AUTO-ANTIBODY EIA TEST KIT, Substantially Equivalent on 1993-02-05. Applicant: Joldon Diagnostics. Device class: 2.

Clearance details

Applicant: Joldon Diagnostics
Product code: Code JZO
Device class: Class 2
Regulation: 21 CFR 866.5870
Advisory panel: Immunology
Date received: 1992-10-15
Decision date: 1993-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scarborough, Ontario, CA

Download summary PDF View on FDA.gov ↗

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