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FDA 510(k)

Lumipulse G TSH-III Immunoreaction Cartridges

K-Number: K171103 · 2017-07-28

ApplicantFujirebio Diagnostics,Inc.
Decision Date2017-07-28
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Lumipulse G TSH-III Immunoreaction Cartridges is a medical device manufactured by Fujirebio Diagnostics,Inc.. It received FDA 510(k) clearance on 2017-07-28 under approval number K171103. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lumipulse G TSH-III Immunoreaction Cartridges?

Lumipulse G TSH-III Immunoreaction Cartridges is a medical device that received FDA 510(k) clearance on 2017-07-28. It is manufactured by Fujirebio Diagnostics,Inc.. The 510(k) number is K171103.

When was Lumipulse G TSH-III Immunoreaction Cartridges approved by the FDA?

Lumipulse G TSH-III Immunoreaction Cartridges received FDA 510(k) clearance on 2017-07-28, under approval number K171103.

What company makes Lumipulse G TSH-III Immunoreaction Cartridges?

Lumipulse G TSH-III Immunoreaction Cartridges is manufactured by Fujirebio Diagnostics,Inc..

What is the FDA product code for Lumipulse G TSH-III Immunoreaction Cartridges?

The FDA product code for Lumipulse G TSH-III Immunoreaction Cartridges is JLW.

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Related Devices (Code: JLW)

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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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