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FDA 510(k)

Lumipulse G Prolactin

K-Number: K163544 · 2017-01-12

ApplicantFujirebio Diagnostics,Inc.
Decision Date2017-01-12
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Lumipulse G Prolactin 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 2017-01-12 under 510(k) number K163544. 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 Prolactin?

Lumipulse G Prolactin is a medical device that received FDA 510(k) clearance on 2017-01-12. The listed applicant is Fujirebio Diagnostics,Inc.. The 510(k) number is K163544.

When did Lumipulse G Prolactin receive FDA 510(k) clearance?

Lumipulse G Prolactin received FDA 510(k) clearance on 2017-01-12, under 510(k) number K163544.

Who is the listed applicant for Lumipulse G Prolactin?

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 Prolactin?

The FDA product code for Lumipulse G Prolactin is JIT.

Other records listing Fujirebio Diagnostics,Inc. as applicant

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Related Devices (Code: JIT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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