Cleared Traditional

Elecsys TSH

K190773 · Roche Diagnostics · Chemistry
Apr 2019
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K190773 is an FDA 510(k) clearance for the Elecsys TSH, a Radioimmunoassay, Thyroid-stimulating Hormone (Class II — Special Controls, product code JLW), submitted by Roche Diagnostics (Indianapolos, US). The FDA issued a Cleared decision on April 16, 2019, 21 days after receiving the submission on March 26, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1690.

Submission Details

510(k) Number K190773 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 2019
Decision Date April 16, 2019
Days to Decision 21 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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