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FDA 510(k)

Access 25(OH) Vitamin D Total

K-Number: K223503 · 2023-01-19

ApplicantBeckman Coulter, Inc.
Decision Date2023-01-19
Product CodeMRG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Access 25(OH) Vitamin D Total is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2023-01-19 under approval number K223503. 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 Access 25(OH) Vitamin D Total?

Access 25(OH) Vitamin D Total is a medical device that received FDA 510(k) clearance on 2023-01-19. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K223503.

When was Access 25(OH) Vitamin D Total approved by the FDA?

Access 25(OH) Vitamin D Total received FDA 510(k) clearance on 2023-01-19, under approval number K223503.

What company makes Access 25(OH) Vitamin D Total?

Access 25(OH) Vitamin D Total is manufactured by Beckman Coulter, Inc..

What is the FDA product code for Access 25(OH) Vitamin D Total?

The FDA product code for Access 25(OH) Vitamin D Total 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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