Cleared Traditional

PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT

K854324 · Pantex, Div. Bio-Analysis, Inc. · Chemistry
Dec 1985
Decision
38d
Days
Class 2
Risk

About This 510(k) Submission

K854324 is an FDA 510(k) clearance for the PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT, a Radioimmunoassay, Total Thyroxine (Class II — Special Controls, product code CDX), submitted by Pantex, Div. Bio-Analysis, Inc. (Santa Monica, US). The FDA issued a Cleared decision on December 5, 1985, 38 days after receiving the submission on October 28, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1700.

Submission Details

510(k) Number K854324 FDA.gov
FDA Decision Cleared SESE
Date Received October 28, 1985
Decision Date December 05, 1985
Days to Decision 38 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

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

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