BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN— 510(k) K033454

Name: FDA 510(k) clearance K033454
Creator: U.S. Food and Drug Administration
Published: 2004-03-22

Substantially Equivalent

Brahms Diagnostica, LLC

FDA 510(k) clearance K033454 for BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN, Substantially Equivalent on 2004-03-22. Applicant: Brahms Diagnostica, LLC. Device class: 2.

Clearance details

Applicant: Brahms Diagnostica, LLC
Product code: Code JZO
Device class: Class 2
Regulation: 21 CFR 866.5870
Advisory panel: Immunology
Date received: 2003-10-30
Decision date: 2004-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

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