Cleared Traditional

TSH (MICROWELL) ELISA

K962216 · Biomerica, Inc. · Chemistry
Sep 1996
Decision
101d
Days
Class 2
Risk

About This 510(k) Submission

K962216 is an FDA 510(k) clearance for the TSH (MICROWELL) ELISA, a Radioimmunoassay, Thyroid-stimulating Hormone (Class II — Special Controls, product code JLW), submitted by Biomerica, Inc. (Newport Beach, US). The FDA issued a Cleared decision on September 19, 1996, 101 days after receiving the submission on June 10, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1690.

Submission Details

510(k) Number K962216 FDA.gov
FDA Decision Cleared SESE
Date Received June 10, 1996
Decision Date September 19, 1996
Days to Decision 101 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JLW — Radioimmunoassay, Thyroid-stimulating Hormone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1690

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