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FDA 510(k)

BioPlex 2200 25-OH Vitamin D Kit

K-Number: K180577 · 2018-06-22

ApplicantBio-Rad Laboratories
Decision Date2018-06-22
Product CodeMRG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BioPlex 2200 25-OH Vitamin D Kit is a medical device manufactured by Bio-Rad Laboratories. It received FDA 510(k) clearance on 2018-06-22 under approval number K180577. 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 BioPlex 2200 25-OH Vitamin D Kit?

BioPlex 2200 25-OH Vitamin D Kit is a medical device that received FDA 510(k) clearance on 2018-06-22. It is manufactured by Bio-Rad Laboratories. The 510(k) number is K180577.

When was BioPlex 2200 25-OH Vitamin D Kit approved by the FDA?

BioPlex 2200 25-OH Vitamin D Kit received FDA 510(k) clearance on 2018-06-22, under approval number K180577.

What company makes BioPlex 2200 25-OH Vitamin D Kit?

BioPlex 2200 25-OH Vitamin D Kit is manufactured by Bio-Rad Laboratories.

What is the FDA product code for BioPlex 2200 25-OH Vitamin D Kit?

The FDA product code for BioPlex 2200 25-OH Vitamin D Kit 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 K153361Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D CalibratorsFujirebio Diagnostics,Inc. 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.

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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