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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 a medical device manufactured by Fujirebio Diagnostics,Inc.. It received FDA 510(k) clearance on 2016-04-15 under approval 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. It is manufactured by Fujirebio Diagnostics,Inc.. The 510(k) number is K153361.

When was Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators approved by the FDA?

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

What company makes 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 manufactured by Fujirebio Diagnostics,Inc..

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)

K161831IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control SetImmunodiagnostic Systems , Ltd. K153375ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 ControlsAbbott Laboratories K162298LOCI Total Vitamin D Total Assay, LOCI VITD CALSiemens Healthcare Diagnostics K162840Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5Roche Diagnostics K162754FREND Vitamin D Test SystemNanoentek USA, Inc. K180577BioPlex 2200 25-OH Vitamin D KitBio-Rad Laboratories

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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