Cleared Traditional

MICROSOMAL EIA TEST KIT

K941361 · Immunoprobe, Inc. · Immunology
May 1994
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K941361 is an FDA 510(k) clearance for the MICROSOMAL 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 May 11, 1994, 51 days after receiving the submission on March 21, 1994. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5870.

Submission Details

510(k) Number K941361 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 1994
Decision Date May 11, 1994
Days to Decision 51 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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