Cleared Traditional

OPUS FT4 TEST SYSTEM

K940507 · Pb Diagnostic Systems, Inc. · Chemistry
Jul 1994
Decision
176d
Days
Class 2
Risk

About This 510(k) Submission

K940507 is an FDA 510(k) clearance for the OPUS FT4 TEST SYSTEM, a Radioimmunoassay, Free Thyroxine (Class II — Special Controls, product code CEC), submitted by Pb Diagnostic Systems, Inc. (Westwood, US). The FDA issued a Cleared decision on July 28, 1994, 176 days after receiving the submission on February 2, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1695.

Submission Details

510(k) Number K940507 FDA.gov
FDA Decision Cleared SESE
Date Received February 02, 1994
Decision Date July 28, 1994
Days to Decision 176 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

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