Cleared Traditional

NEOCOAT T4

K901939 · Neometrics, Inc. · Chemistry
May 1990
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K901939 is an FDA 510(k) clearance for the NEOCOAT T4, a Radioimmunoassay, Total Thyroxine (Class II — Special Controls, product code CDX), submitted by Neometrics, Inc. (E. Northport, US). The FDA issued a Cleared decision on May 31, 1990, 31 days after receiving the submission on April 30, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1700.

Submission Details

510(k) Number K901939 FDA.gov
FDA Decision Cleared SESE
Date Received April 30, 1990
Decision Date May 31, 1990
Days to Decision 31 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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