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FDA 510(k)

Elecsys Anti-HAV II

K-Number: K190428 · 2019-08-13

ApplicantRoche Diagnostics
Decision Date2019-08-13
Product CodeLOL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Elecsys Anti-HAV II is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2019-08-13 under 510(k) number K190428. 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 Elecsys Anti-HAV II?

Elecsys Anti-HAV II is a medical device that received FDA 510(k) clearance on 2019-08-13. The listed applicant is Roche Diagnostics. The 510(k) number is K190428.

When did Elecsys Anti-HAV II receive FDA 510(k) clearance?

Elecsys Anti-HAV II received FDA 510(k) clearance on 2019-08-13, under 510(k) number K190428.

Who is the listed applicant for Elecsys Anti-HAV II?

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

What is the FDA product code for Elecsys Anti-HAV II?

The FDA product code for Elecsys Anti-HAV II is LOL.

Other records listing Roche Diagnostics 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.

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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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