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FDA 510(k)

ALFIS Vitamin D, ALFIS-3 Analyzer

K-Number: K221817 · 2023-09-22

ApplicantImmunostics Inc.,
Decision Date2023-09-22
Product CodeMRG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALFIS Vitamin D, ALFIS-3 Analyzer is a medical device manufactured by Immunostics Inc.,. It received FDA 510(k) clearance on 2023-09-22 under approval number K221817. 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 ALFIS Vitamin D, ALFIS-3 Analyzer?

ALFIS Vitamin D, ALFIS-3 Analyzer is a medical device that received FDA 510(k) clearance on 2023-09-22. It is manufactured by Immunostics Inc.,. The 510(k) number is K221817.

When was ALFIS Vitamin D, ALFIS-3 Analyzer approved by the FDA?

ALFIS Vitamin D, ALFIS-3 Analyzer received FDA 510(k) clearance on 2023-09-22, under approval number K221817.

What company makes ALFIS Vitamin D, ALFIS-3 Analyzer?

ALFIS Vitamin D, ALFIS-3 Analyzer is manufactured by Immunostics Inc.,.

What is the FDA product code for ALFIS Vitamin D, ALFIS-3 Analyzer?

The FDA product code for ALFIS Vitamin D, ALFIS-3 Analyzer is MRG.

Other Devices by Immunostics Inc.,

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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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