BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS— 510(k) K021057

Name: FDA 510(k) clearance K021057
Creator: U.S. Food and Drug Administration
Published: 2002-09-17

Substantially Equivalent

Brahms Diagnostica, LLC

FDA 510(k) clearance K021057 for BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS, Substantially Equivalent on 2002-09-17. Applicant: Brahms Diagnostica, LLC. Device class: 2.

Clearance details

Applicant: Brahms Diagnostica, LLC
Product code: Code MSW
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 2002-04-01
Decision date: 2002-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

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