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FDA 510(k)

DIASORIN LIAISON TREPONEMA ASSAY

K-Number: K061247 · 2006-07-31

ApplicantDiaSorin, Inc.
Decision Date2006-07-31
Product CodeLIP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DIASORIN LIAISON TREPONEMA ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2006-07-31 under 510(k) number K061247. The device is classified under product code LIP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIASORIN LIAISON TREPONEMA ASSAY?

DIASORIN LIAISON TREPONEMA ASSAY is a medical device that received FDA 510(k) clearance on 2006-07-31. The listed applicant is DiaSorin, Inc.. The 510(k) number is K061247.

When did DIASORIN LIAISON TREPONEMA ASSAY receive FDA 510(k) clearance?

DIASORIN LIAISON TREPONEMA ASSAY received FDA 510(k) clearance on 2006-07-31, under 510(k) number K061247.

Who is the listed applicant for DIASORIN LIAISON TREPONEMA ASSAY?

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

What is the FDA product code for DIASORIN LIAISON TREPONEMA ASSAY?

The FDA product code for DIASORIN LIAISON TREPONEMA ASSAY is LIP.

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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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