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FDA 510(k)

Access anti-HAV IgM

K-Number: K251995 · 2026-01-27

ApplicantBeckman Coulter, Inc.
Decision Date2026-01-27
Product CodeLOL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Access anti-HAV IgM 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 2026-01-27 under 510(k) number K251995. The device is classified under product code LOL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Access anti-HAV IgM?

Access anti-HAV IgM is a medical device that received FDA 510(k) clearance on 2026-01-27. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K251995.

When did Access anti-HAV IgM receive FDA 510(k) clearance?

Access anti-HAV IgM received FDA 510(k) clearance on 2026-01-27, under 510(k) number K251995.

Who is the listed applicant for Access anti-HAV IgM?

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 anti-HAV IgM?

The FDA product code for Access anti-HAV IgM is LOL.

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 IIK254059Access anti-HBc IgMK253687Access anti-HBc TotalK250588Access Rubella IgGPMA P980041KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTSPMA P230015Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

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Related Devices (Code: LOL)

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.

K260048Elecsys Anti-HAV IgMRoche DiagnosticsK243846Access anti-HAVBeckman Coulter, Inc.K222850HAVAb IgG IIAbbott LaboratoriesK223403LIAISON Anti-HAV; LIAISON XSDiaSorin, Inc.K210272LIAISON Anti-HAVDiaSorin, Inc.K193532LIAISON Anti-HAV AssayDiaSorin, Inc.

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.

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