Cleared Traditional

ACTIVE THYROXINE RIA

K954312 · Diagnostic Systems Laboratories, Inc. · Chemistry
Oct 1995
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K954312 is an FDA 510(k) clearance for the ACTIVE THYROXINE RIA, a Radioimmunoassay, Total Thyroxine (Class II — Special Controls, product code CDX), submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on October 7, 1995, 22 days after receiving the submission on September 15, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1700.

Submission Details

510(k) Number K954312 FDA.gov
FDA Decision Cleared SESE
Date Received September 15, 1995
Decision Date October 07, 1995
Days to Decision 22 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CDX — Radioimmunoassay, Total Thyroxine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1700

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