Cleared Traditional

STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO

K933426 · Baxter Diagnostics, Inc. · Chemistry
Aug 1993
Decision
44d
Days
Class 2
Risk

About This 510(k) Submission

K933426 is an FDA 510(k) clearance for the STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO, a Radioimmunoassay, Total Thyroxine (Class II — Special Controls, product code CDX), submitted by Baxter Diagnostics, Inc. (Miami, US). The FDA issued a Cleared decision on August 26, 1993, 44 days after receiving the submission on July 13, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1700.

Submission Details

510(k) Number K933426 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 1993
Decision Date August 26, 1993
Days to Decision 44 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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