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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 a medical device manufactured by Diagnostica Stago. It received FDA 510(k) clearance on 2016-12-10 under approval 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. It is manufactured by Diagnostica Stago. The 510(k) number is K162227.

When was STA® - Liatest® D-Di approved by the FDA?

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

What company makes STA® - Liatest® D-Di?

STA® - Liatest® D-Di is manufactured by Diagnostica Stago.

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

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

Related Devices (Code: DAP)

Official Source

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