FDA 510(k)

Lumipulse G whole PTH

K-Number: K190702 · 2019-08-30

Decision Date2019-08-30

Product CodeCEW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

Lumipulse G whole PTH is a medical device manufactured by Fujirebio Diagnostics,Inc.. It received FDA 510(k) clearance on 2019-08-30 under approval number K190702. The device is classified under product code CEW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lumipulse G whole PTH?

Lumipulse G whole PTH is a medical device that received FDA 510(k) clearance on 2019-08-30. It is manufactured by Fujirebio Diagnostics,Inc.. The 510(k) number is K190702.

When was Lumipulse G whole PTH approved by the FDA?

Lumipulse G whole PTH received FDA 510(k) clearance on 2019-08-30, under approval number K190702.

What company makes Lumipulse G whole PTH?

Lumipulse G whole PTH is manufactured by Fujirebio Diagnostics,Inc..

What is the FDA product code for Lumipulse G whole PTH?

The FDA product code for Lumipulse G whole PTH is CEW.

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Related Devices (Code: CEW)

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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.