Cleared Traditional

V-TREND EIA TSH

K861918 · V-Tech, Inc. · Chemistry
Jul 1986
Decision
44d
Days
Class 2
Risk

About This 510(k) Submission

K861918 is an FDA 510(k) clearance for the V-TREND EIA TSH, a Radioimmunoassay, Thyroid-stimulating Hormone (Class II — Special Controls, product code JLW), submitted by V-Tech, Inc. (Pomona, US). The FDA issued a Cleared decision on July 2, 1986, 44 days after receiving the submission on May 19, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1690.

Submission Details

510(k) Number K861918 FDA.gov
FDA Decision Cleared SESE
Date Received May 19, 1986
Decision Date July 02, 1986
Days to Decision 44 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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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