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FDA 510(k)

ARCHITECT HAVAB-G

K-Number: K113704 · 2012-06-28

ApplicantAbbott Laboratories
Decision Date2012-06-28
Product CodeLOL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ARCHITECT HAVAB-G is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2012-06-28 under 510(k) number K113704. 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 ARCHITECT HAVAB-G?

ARCHITECT HAVAB-G is a medical device that received FDA 510(k) clearance on 2012-06-28. The listed applicant is Abbott Laboratories. The 510(k) number is K113704.

When did ARCHITECT HAVAB-G receive FDA 510(k) clearance?

ARCHITECT HAVAB-G received FDA 510(k) clearance on 2012-06-28, under 510(k) number K113704.

Who is the listed applicant for ARCHITECT HAVAB-G?

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 ARCHITECT HAVAB-G?

The FDA product code for ARCHITECT HAVAB-G is LOL.

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Other records listing Abbott Laboratories as applicant

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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.K222850HAVAb IgG IIAbbott LaboratoriesK223403LIAISON Anti-HAV; LIAISON XSDiaSorin, Inc.K210272LIAISON Anti-HAVDiaSorin, 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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