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FDA 510(k)

Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators

K-Number: K153361 · 2016-04-15

ApplicantFujirebio Diagnostics,Inc.
Decision Date2016-04-15
Product CodeMRG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D 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 2016-04-15 under 510(k) number K153361. The device is classified under product code MRG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators?

Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators is a medical device that received FDA 510(k) clearance on 2016-04-15. The listed applicant is Fujirebio Diagnostics,Inc.. The 510(k) number is K153361.

When did Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators receive FDA 510(k) clearance?

Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators received FDA 510(k) clearance on 2016-04-15, under 510(k) number K153361.

Who is the listed applicant for Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D 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 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators?

The FDA product code for Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators is MRG.

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Related Devices (Code: MRG)

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.

K232587MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzerShenzhen New Industries Biomedical Engineering Co., Ltd.K221817ALFIS Vitamin D, ALFIS-3 AnalyzerImmunostics Inc.,K223503Access 25(OH) Vitamin D TotalBeckman Coulter, Inc.K210901Elecsys Vitamin D total IIIRoche DiagnosticsK200509ADVIA Centaur Vitamin D Total (VitD)Siemens Healthcare Diagnostics, Inc.K191499MAGLUMI 2000 25-OH Vitamin DShenzhen New Industries Biomedical Engineering Co., Ltd.

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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