Cleared Traditional

ADVIA Centaur? TSH3-Ultra II (TSH3ULII)

K233050 · Siemens Healthcare Diagnostics, Inc. · Chemistry
Apr 2024
Decision
192d
Days
Class 2
Risk

About This 510(k) Submission

K233050 is an FDA 510(k) clearance for the ADVIA Centaur? TSH3-Ultra II (TSH3ULII), a Radioimmunoassay, Thyroid-stimulating Hormone (Class II — Special Controls, product code JLW), submitted by Siemens Healthcare Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on April 4, 2024, 192 days after receiving the submission on September 25, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1690.

Submission Details

510(k) Number K233050 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 2023
Decision Date April 04, 2024
Days to Decision 192 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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