Cleared Traditional

Access Syphilis

K241427 · Beckman Coulter, Inc. · Microbiology
Sep 2024
Decision
109d
Days
Class 2
Risk

About This 510(k) Submission

K241427 is an FDA 510(k) clearance for the Access Syphilis, a Enzyme Linked Immunoabsorption Assay, Treponema Pallidum (Class II — Special Controls, product code LIP), submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on September 6, 2024, 109 days after receiving the submission on May 20, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number K241427 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 2024
Decision Date September 06, 2024
Days to Decision 109 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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