FDA 510(k)

STA® - Liatest® D-Di

K-Number: K162227 · 2016-12-10

Decision Date2016-12-10

Product CodeDAP

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

STA® - Liatest® D-Di is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostica Stago. It received FDA 510(k) clearance on 2016-12-10 under 510(k) number K162227. The device is classified under product code DAP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STA® - Liatest® D-Di?

STA® - Liatest® D-Di is a medical device that received FDA 510(k) clearance on 2016-12-10. The listed applicant is Diagnostica Stago. The 510(k) number is K162227.

When did STA® - Liatest® D-Di receive FDA 510(k) clearance?

STA® - Liatest® D-Di received FDA 510(k) clearance on 2016-12-10, under 510(k) number K162227.

Who is the listed applicant for STA® - Liatest® D-Di?

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

What is the FDA product code for STA® - Liatest® D-Di?

The FDA product code for STA® - Liatest® D-Di is DAP.

Other records listing Diagnostica Stago 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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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.