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FDA 510(k)

HAVAb IgG II

K-Number: K222850 · 2023-08-10

ApplicantAbbott Laboratories
Decision Date2023-08-10
Product CodeLOL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HAVAb IgG II is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2023-08-10 under 510(k) number K222850. 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 HAVAb IgG II?

HAVAb IgG II is a medical device that received FDA 510(k) clearance on 2023-08-10. The listed applicant is Abbott Laboratories. The 510(k) number is K222850.

When did HAVAb IgG II receive FDA 510(k) clearance?

HAVAb IgG II received FDA 510(k) clearance on 2023-08-10, under 510(k) number K222850.

Who is the listed applicant for HAVAb IgG II?

The FDA 510(k) record lists Abbott Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HAVAb IgG II?

The FDA product code for HAVAb IgG II is LOL.

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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.K243846Access anti-HAVBeckman Coulter, Inc.K223403LIAISON 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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