Cleared Traditional

BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS

K021057 · Brahms Diagnostica, LLC · Immunology
Sep 2002
Decision
169d
Days
Class 2
Risk

About This 510(k) Submission

K021057 is an FDA 510(k) clearance for the BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS, a System, Test, Thyroglobulin (Class II — Special Controls, product code MSW), submitted by Brahms Diagnostica, LLC (Norcross, US). The FDA issued a Cleared decision on September 17, 2002, 169 days after receiving the submission on April 1, 2002. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K021057 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 2002
Decision Date September 17, 2002
Days to Decision 169 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code MSW — System, Test, Thyroglobulin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.6010

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