DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368— 510(k) K032692

Name: FDA 510(k) clearance K032692
Creator: U.S. Food and Drug Administration
Published: 2004-01-22

Substantially Equivalent

Dako A/S

FDA 510(k) clearance K032692 for DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368, Substantially Equivalent on 2004-01-22. Applicant: Dako A/S. Device class: 2.

Clearance details

Applicant: Dako A/S
Product code: Code JZG
Device class: Class 2
Regulation: 21 CFR 866.5630
Advisory panel: Immunology
Date received: 2003-09-02
Decision date: 2004-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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