Cleared Traditional

BRAHMS DIAGNOSTICA DYNOTEST ANTI-TPO

K992791 · Brahms Diagnostica, LLC · Immunology
Nov 1999
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K992791 is an FDA 510(k) clearance for the BRAHMS DIAGNOSTICA DYNOTEST ANTI-TPO, a System, Test, Thyroid Autoantibody (Class II — Special Controls, product code JZO), submitted by Brahms Diagnostica, LLC (Norcross, US). The FDA issued a Cleared decision on November 12, 1999, 85 days after receiving the submission on August 19, 1999. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5870.

Submission Details

510(k) Number K992791 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 1999
Decision Date November 12, 1999
Days to Decision 85 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code JZO — System, Test, Thyroid Autoantibody
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5870

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