Cleared Traditional

ACCESS TOTAL T4 ASSAY

K023369 · Beckman Coulter, Inc. · Chemistry
Dec 2002
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K023369 is an FDA 510(k) clearance for the ACCESS TOTAL T4 ASSAY, a Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (Class II — Special Controls, product code KLI), submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on December 9, 2002, 62 days after receiving the submission on October 8, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1700.

Submission Details

510(k) Number K023369 FDA.gov
FDA Decision Cleared SESE
Date Received October 08, 2002
Decision Date December 09, 2002
Days to Decision 62 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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