Cleared Traditional

VITROS Immunodiagnostic Products Syphilis Reagent Pack

K241534 · Ortho-Clinical Diagnostics · Microbiology
Aug 2024
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K241534 is an FDA 510(k) clearance for the VITROS Immunodiagnostic Products Syphilis Reagent Pack, a Enzyme Linked Immunoabsorption Assay, Treponema Pallidum (Class II — Special Controls, product code LIP), submitted by Ortho-Clinical Diagnostics (Bridgend, GB). The FDA issued a Cleared decision on August 28, 2024, 90 days after receiving the submission on May 30, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number K241534 FDA.gov
FDA Decision Cleared SESE
Date Received May 30, 2024
Decision Date August 28, 2024
Days to Decision 90 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LIP — Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3830

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