Cleared Traditional

HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG)

K962341 · Hycor Biomedical, Inc. · Immunology
Nov 1996
Decision
160d
Days
Class 2
Risk

About This 510(k) Submission

K962341 is an FDA 510(k) clearance for the HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG), a Immunochemical, Thyroglobulin Autoantibody (Class II — Special Controls, product code JNL), submitted by Hycor Biomedical, Inc. (Garden Grove, US). The FDA issued a Cleared decision on November 25, 1996, 160 days after receiving the submission on June 18, 1996. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5870.

Submission Details

510(k) Number K962341 FDA.gov
FDA Decision Cleared SESE
Date Received June 18, 1996
Decision Date November 25, 1996
Days to Decision 160 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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