Access Rubella IgG
K-Number: K250588 · 2025-11-17
ApplicantBeckman Coulter, Inc.
Decision Date2025-11-17
Product CodeLFX
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
Access Rubella IgG is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2025-11-17 under approval number K250588. The device is classified under product code LFX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Access Rubella IgG?
Access Rubella IgG is a medical device that received FDA 510(k) clearance on 2025-11-17. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K250588.
When was Access Rubella IgG approved by the FDA?
Access Rubella IgG received FDA 510(k) clearance on 2025-11-17, under approval number K250588.
What company makes Access Rubella IgG?
Access Rubella IgG is manufactured by Beckman Coulter, Inc..
What is the FDA product code for Access Rubella IgG?
The FDA product code for Access Rubella IgG is LFX.
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Related Devices (Code: LFX)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.