Cleared Traditional

DELFIA FREE THYROXINE (FT4) KIT

K894605 · Pharmacia, Inc. · Chemistry
Sep 1989
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K894605 is an FDA 510(k) clearance for the DELFIA FREE THYROXINE (FT4) KIT, a Radioimmunoassay, Free Thyroxine (Class II — Special Controls, product code CEC), submitted by Pharmacia, Inc. (Piscataway, US). The FDA issued a Cleared decision on September 18, 1989, 60 days after receiving the submission on July 20, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1695.

Submission Details

510(k) Number K894605 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 1989
Decision Date September 18, 1989
Days to Decision 60 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CEC — Radioimmunoassay, Free Thyroxine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1695