KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KIT— 510(k) K915428

Name: FDA 510(k) clearance K915428
Creator: U.S. Food and Drug Administration
Published: 1992-03-30

Substantially Equivalent

Kronus

FDA 510(k) clearance K915428 for KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KIT, Substantially Equivalent on 1992-03-30. Applicant: Kronus. Device class: 2.

Clearance details

Applicant: Kronus
Product code: Code JZO
Device class: Class 2
Regulation: 21 CFR 866.5870
Advisory panel: Immunology
Date received: 1991-12-02
Decision date: 1992-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dana Point, CA, US

Download summary PDF View on FDA.gov ↗

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