Cleared Traditional

Elecsys PTH , Elecsys PTH STAT

K231927 · Roche Diagnostics · Chemistry
Mar 2024
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K231927 is an FDA 510(k) clearance for the Elecsys PTH , Elecsys PTH STAT, a Radioimmunoassay, Parathyroid Hormone (Class II — Special Controls, product code CEW), submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on March 22, 2024, 266 days after receiving the submission on June 30, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1545.

Submission Details

510(k) Number K231927 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 2023
Decision Date March 22, 2024
Days to Decision 266 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CEW — Radioimmunoassay, Parathyroid Hormone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1545

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