Cleared Traditional

Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer

K221225 · Beckman Coulter, Inc. · Chemistry
Nov 2022
Decision
196d
Days
Class 2
Risk

About This 510(k) Submission

K221225 is an FDA 510(k) clearance for the Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer, a Radioimmunoassay, Thyroid-stimulating Hormone (Class II — Special Controls, product code JLW), submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on November 10, 2022, 196 days after receiving the submission on April 28, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1690.

Submission Details

510(k) Number K221225 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 2022
Decision Date November 10, 2022
Days to Decision 196 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JLW — Radioimmunoassay, Thyroid-stimulating Hormone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1690

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