Cleared Traditional

ACCUWELL T4-EIA

K972974 · Neometrics, Inc. · Chemistry
Oct 1997
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K972974 is an FDA 510(k) clearance for the ACCUWELL T4-EIA, a Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (Class II — Special Controls, product code KLI), submitted by Neometrics, Inc. (E. Northport, US). The FDA issued a Cleared decision on October 6, 1997, 56 days after receiving the submission on August 11, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1700.

Submission Details

510(k) Number K972974 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 1997
Decision Date October 06, 1997
Days to Decision 56 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code KLI — Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1700

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