FDA 510(k)

Lumipulse G TP-N Immunoreaction Cartridge Set

K-Number: K153145 · 2016-07-05

Decision Date2016-07-05

Product CodeLIP

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Lumipulse G TP-N Immunoreaction Cartridge Set is the device name listed in this FDA 510(k) record. The listed applicant is Fujirebio Diagnostics,Inc.. It received FDA 510(k) clearance on 2016-07-05 under 510(k) 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. The listed applicant is Fujirebio Diagnostics,Inc.. The 510(k) number is K153145.

When did Lumipulse G TP-N Immunoreaction Cartridge Set receive FDA 510(k) clearance?

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

Who is the listed applicant for Lumipulse G TP-N Immunoreaction Cartridge Set?

The FDA 510(k) record lists Fujirebio Diagnostics,Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Fujirebio Diagnostics,Inc. as applicant

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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.