Cleared Traditional

AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT

K944490 · Wallac OY · Toxicology
Dec 1994
Decision
87d
Days
Class 1
Risk

About This 510(k) Submission

K944490 is an FDA 510(k) clearance for the AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT, a Radioimmunoassay, Estriol (Class I — General Controls, product code CGI), submitted by Wallac OY (Turku, FI). The FDA issued a Cleared decision on December 9, 1994, 87 days after receiving the submission on September 13, 1994. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1265.

Submission Details

510(k) Number K944490 FDA.gov
FDA Decision Cleared SESE
Date Received September 13, 1994
Decision Date December 09, 1994
Days to Decision 87 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code CGI — Radioimmunoassay, Estriol
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1265

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