FDA 510(k)

Access Rubella IgG

K-Number: K250588 · 2025-11-17

Decision Date2025-11-17

Product CodeLFX

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Access Rubella IgG is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2025-11-17 under 510(k) 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. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K250588.

When did Access Rubella IgG receive FDA 510(k) clearance?

Access Rubella IgG received FDA 510(k) clearance on 2025-11-17, under 510(k) number K250588.

Who is the listed applicant for Access Rubella IgG?

The FDA 510(k) record lists Beckman Coulter, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Access Rubella IgG?

The FDA product code for Access Rubella IgG is LFX.

Other records listing Beckman Coulter, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252169Access BNP II K254059Access anti-HBc IgM K253687Access anti-HBc Total K251995Access anti-HAV IgM PMA P980041KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS PMA P230015Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

View all 84 devices →

Related Devices (Code: LFX)

K243168Alinity i Rubella IgGAbbott Laboratories

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.