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FDA 510(k)

VIDAS AFP ASSAY

K-Number: K080017 · 2008-09-26

ApplicantbioMerieux, Inc.
Decision Date2008-09-26
Product CodeLOJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

VIDAS AFP ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2008-09-26 under 510(k) number K080017. The device is classified under product code LOJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIDAS AFP ASSAY?

VIDAS AFP ASSAY is a medical device that received FDA 510(k) clearance on 2008-09-26. The listed applicant is bioMerieux, Inc.. The 510(k) number is K080017.

When did VIDAS AFP ASSAY receive FDA 510(k) clearance?

VIDAS AFP ASSAY received FDA 510(k) clearance on 2008-09-26, under 510(k) number K080017.

Who is the listed applicant for VIDAS AFP ASSAY?

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

What is the FDA product code for VIDAS AFP ASSAY?

The FDA product code for VIDAS AFP ASSAY is LOJ.

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Related Devices (Code: LOJ)

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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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