Cleared Traditional

VITROS Immunodiagnostic Products Intact PTH II Reagent Pack

K221197 · Ortho-Clinical Diagnostics · Chemistry
Sep 2023
Decision
498d
Days
Class 2
Risk

About This 510(k) Submission

K221197 is an FDA 510(k) clearance for the VITROS Immunodiagnostic Products Intact PTH II Reagent Pack, a Radioimmunoassay, Parathyroid Hormone (Class II — Special Controls, product code CEW), submitted by Ortho-Clinical Diagnostics (Bridgend, GB). The FDA issued a Cleared decision on September 5, 2023, 498 days after receiving the submission on April 25, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1545.

Submission Details

510(k) Number K221197 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 2022
Decision Date September 05, 2023
Days to Decision 498 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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