FDA 510(k)

ANTI-HAV

K-Number: K100903 · 2010-10-05

Decision Date2010-10-05

Product CodeLOL

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

ANTI-HAV is the device name listed in this FDA 510(k) record. The listed applicant is Roche Professional Diagnostics. It received FDA 510(k) clearance on 2010-10-05 under 510(k) number K100903. 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 ANTI-HAV?

ANTI-HAV is a medical device that received FDA 510(k) clearance on 2010-10-05. The listed applicant is Roche Professional Diagnostics. The 510(k) number is K100903.

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

ANTI-HAV received FDA 510(k) clearance on 2010-10-05, under 510(k) number K100903.

Who is the listed applicant for ANTI-HAV?

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

What is the FDA product code for ANTI-HAV?

The FDA product code for ANTI-HAV is LOL.

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 Diagnostics K251995Access anti-HAV IgMBeckman Coulter, Inc.K243846Access anti-HAVBeckman Coulter, Inc.K222850HAVAb IgG IIAbbott Laboratories K223403LIAISON Anti-HAV; LIAISON XSDiaSorin, Inc.K210272LIAISON Anti-HAVDiaSorin, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.