Cleared Traditional

ANTI-TPO

K954256 · Biomerica, Inc. · Immunology
Nov 1995
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K954256 is an FDA 510(k) clearance for the ANTI-TPO, a Immunochemical, Thyroglobulin Autoantibody (Class II — Special Controls, product code JNL), submitted by Biomerica, Inc. (Newport Beach, US). The FDA issued a Cleared decision on November 27, 1995, 83 days after receiving the submission on September 5, 1995. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5870.

Submission Details

510(k) Number K954256 FDA.gov
FDA Decision Cleared SESE
Date Received September 05, 1995
Decision Date November 27, 1995
Days to Decision 83 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code JNL — Immunochemical, Thyroglobulin Autoantibody
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5870

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