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FDA 510(k)

U&U Blood Collection Sets

K-Number: K181508 · 2019-02-13

ApplicantU&U Medical Technology Co, Ltd.
Decision Date2019-02-13
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

U&U Blood Collection Sets is a medical device manufactured by U&U Medical Technology Co, Ltd.. It received FDA 510(k) clearance on 2019-02-13 under approval number K181508. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the U&U Blood Collection Sets?

U&U Blood Collection Sets is a medical device that received FDA 510(k) clearance on 2019-02-13. It is manufactured by U&U Medical Technology Co, Ltd.. The 510(k) number is K181508.

When was U&U Blood Collection Sets approved by the FDA?

U&U Blood Collection Sets received FDA 510(k) clearance on 2019-02-13, under approval number K181508.

What company makes U&U Blood Collection Sets?

U&U Blood Collection Sets is manufactured by U&U Medical Technology Co, Ltd..

What is the FDA product code for U&U Blood Collection Sets?

The FDA product code for U&U Blood Collection Sets is FMI.

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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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