Cleared Traditional

V-TREND EIA T4 ENZYME IMMUNOASSAY TEST KIT

K854971 · V-Tech, Inc. · Chemistry
Feb 1986
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K854971 is an FDA 510(k) clearance for the V-TREND EIA T4 ENZYME IMMUNOASSAY TEST KIT, a Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (Class II — Special Controls, product code KLI), submitted by V-Tech, Inc. (Pomona, US). The FDA issued a Cleared decision on February 6, 1986, 57 days after receiving the submission on December 11, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1700.

Submission Details

510(k) Number K854971 FDA.gov
FDA Decision Cleared SESE
Date Received December 11, 1985
Decision Date February 06, 1986
Days to Decision 57 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code KLI — Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1700

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