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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 the device name listed in this FDA 510(k) record. The listed applicant is Fujirebio Diagnostics,Inc.. It received FDA 510(k) clearance on 2016-12-01 under 510(k) 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. The listed applicant is Fujirebio Diagnostics,Inc.. The 510(k) number is K163053.

When did Lumipulse G E2-III Calibrators receive FDA 510(k) clearance?

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

Who is the listed applicant for Lumipulse G E2-III Calibrators?

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 E2-III Calibrators?

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

K171168VITROS Immunodiagnostic Products Insulin CalibratorsOrtho Clinical DiagnosticsK170938CalSet IGF-1Roche DiagnosticsK170160Abbott ARCHITECT Free T3Abbott LaboratoriesK163546Lumipulse G Progesterone-N CalibratorsFujirebio Diagnostics,Inc.K163534Lumipulse G FSH-N CalibratorsFujirebio Diagnostics,Inc.K163544Lumipulse G ProlactinFujirebio Diagnostics,Inc.

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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