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FDA 510(k)

Lumipulse G E2-III Calibrators

K-Number: K163053 · 2016-12-01

ApplicantFujirebio Diagnostics,Inc.
Decision Date2016-12-01
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Lumipulse G E2-III Calibrators is a medical device manufactured by Fujirebio Diagnostics,Inc.. It received FDA 510(k) clearance on 2016-12-01 under approval number K163053. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lumipulse G E2-III Calibrators?

Lumipulse G E2-III Calibrators is a medical device that received FDA 510(k) clearance on 2016-12-01. It is manufactured by Fujirebio Diagnostics,Inc.. The 510(k) number is K163053.

When was Lumipulse G E2-III Calibrators approved by the FDA?

Lumipulse G E2-III Calibrators received FDA 510(k) clearance on 2016-12-01, under approval number K163053.

What company makes Lumipulse G E2-III Calibrators?

Lumipulse G E2-III Calibrators is manufactured by Fujirebio Diagnostics,Inc..

What is the FDA product code for Lumipulse G E2-III Calibrators?

The FDA product code for Lumipulse G E2-III Calibrators is JIT.

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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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