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FDA 510(k)

Access hs Tnl

K-Number: K172783 · 2018-06-12

Decision Date2018-06-12
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Access hs Tnl is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2018-06-12 under approval number K172783. The device is classified under product code MMI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Access hs Tnl?

Access hs Tnl is a medical device that received FDA 510(k) clearance on 2018-06-12. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K172783.

When was Access hs Tnl approved by the FDA?

Access hs Tnl received FDA 510(k) clearance on 2018-06-12, under approval number K172783.

What company makes Access hs Tnl?

Access hs Tnl is manufactured by Beckman Coulter, Inc..

What is the FDA product code for Access hs Tnl?

The FDA product code for Access hs Tnl is MMI.

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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.