Cleared Traditional

VITROS Immunodiagnostic Products Total ?-hCG II Reagent Pack

K233581 · Ortho-Clinical Diagnostics · Chemistry
May 2024
Decision
183d
Days
Class 2
Risk

About This 510(k) Submission

K233581 is an FDA 510(k) clearance for the VITROS Immunodiagnostic Products Total ?-hCG II Reagent Pack, a System, Test, Human Chorionic Gonadotropin (Class II — Special Controls, product code DHA), submitted by Ortho-Clinical Diagnostics (Bridgend, GB). The FDA issued a Cleared decision on May 8, 2024, 183 days after receiving the submission on November 7, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K233581 FDA.gov
FDA Decision Cleared SESE
Date Received November 07, 2023
Decision Date May 08, 2024
Days to Decision 183 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DHA — System, Test, Human Chorionic Gonadotropin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155

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