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FDA 510(k)

Access anti-HAV

K-Number: K243846 · 2025-09-09

ApplicantBeckman Coulter, Inc.
Decision Date2025-09-09
Product CodeLOL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Access anti-HAV 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 2025-09-09 under 510(k) number K243846. 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?

Access anti-HAV is a medical device that received FDA 510(k) clearance on 2025-09-09. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K243846.

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

Access anti-HAV received FDA 510(k) clearance on 2025-09-09, under 510(k) number K243846.

Who is the listed applicant for Access anti-HAV?

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?

The FDA product code for Access anti-HAV 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 TotalK251995Access anti-HAV IgMK250588Access Rubella IgGPMA P980041KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS

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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 DiagnosticsK251995Access anti-HAV IgMBeckman 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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