Cleared Traditional

THYROGLOBULIN EIA TEST KIT

K951362 · Immunoprobe, Inc. · Immunology
Nov 1995
Decision
241d
Days
Class 2
Risk

About This 510(k) Submission

K951362 is an FDA 510(k) clearance for the THYROGLOBULIN EIA TEST KIT, a Immunochemical, Thyroglobulin Autoantibody (Class II — Special Controls, product code JNL), submitted by Immunoprobe, Inc. (Washington, US). The FDA issued a Cleared decision on November 20, 1995, 241 days after receiving the submission on March 24, 1995. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5870.

Submission Details

510(k) Number K951362 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 1995
Decision Date November 20, 1995
Days to Decision 241 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

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

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