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FDA 510(k)

Lumipulse G TP-N Immunoreaction Cartridge Set

K-Number: K153145 · 2016-07-05

ApplicantFujirebio Diagnostics,Inc.
Decision Date2016-07-05
Product CodeLIP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Lumipulse G TP-N Immunoreaction Cartridge Set is a medical device manufactured by Fujirebio Diagnostics,Inc.. It received FDA 510(k) clearance on 2016-07-05 under approval number K153145. 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 Lumipulse G TP-N Immunoreaction Cartridge Set?

Lumipulse G TP-N Immunoreaction Cartridge Set is a medical device that received FDA 510(k) clearance on 2016-07-05. It is manufactured by Fujirebio Diagnostics,Inc.. The 510(k) number is K153145.

When was Lumipulse G TP-N Immunoreaction Cartridge Set approved by the FDA?

Lumipulse G TP-N Immunoreaction Cartridge Set received FDA 510(k) clearance on 2016-07-05, under approval number K153145.

What company makes Lumipulse G TP-N Immunoreaction Cartridge Set?

Lumipulse G TP-N Immunoreaction Cartridge Set is manufactured by Fujirebio Diagnostics,Inc..

What is the FDA product code for Lumipulse G TP-N Immunoreaction Cartridge Set?

The FDA product code for Lumipulse G TP-N Immunoreaction Cartridge Set 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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