Cleared Traditional

Access Rubella IgG

K250588 · Beckman Coulter, Inc. · Microbiology
Nov 2025
Decision
263d
Days
Class 2
Risk

About This 510(k) Submission

K250588 is an FDA 510(k) clearance for the Access Rubella IgG, a Enzyme Linked Immunoabsorbent Assay, Rubella (Class II — Special Controls, product code LFX), submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on November 17, 2025, 263 days after receiving the submission on February 27, 2025. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number K250588 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 2025
Decision Date November 17, 2025
Days to Decision 263 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LFX — Enzyme Linked Immunoabsorbent Assay, Rubella
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3510

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