Cleared Traditional

ACCUSCREEN T4

K781222 · Neometrics, Inc. · Chemistry
Nov 1978
Decision
114d
Days
Class 2
Risk

About This 510(k) Submission

K781222 is an FDA 510(k) clearance for the ACCUSCREEN T4, a Radioimmunoassay, Total Thyroxine (Class II — Special Controls, product code CDX), submitted by Neometrics, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 8, 1978, 114 days after receiving the submission on July 17, 1978. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1700.

Submission Details

510(k) Number K781222 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 1978
Decision Date November 08, 1978
Days to Decision 114 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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