Cleared Traditional

ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA

K971834 · Monobind · Immunology
Jul 1997
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K971834 is an FDA 510(k) clearance for the ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA, a Immunochemical, Thyroglobulin Autoantibody (Class II — Special Controls, product code JNL), submitted by Monobind (Costa Mesa, US). The FDA issued a Cleared decision on July 3, 1997, 45 days after receiving the submission on May 19, 1997. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5870.

Submission Details

510(k) Number K971834 FDA.gov
FDA Decision Cleared SESE
Date Received May 19, 1997
Decision Date July 03, 1997
Days to Decision 45 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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