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FDA 510(k)

IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set

K-Number: K161831 · 2016-11-15

ApplicantImmunodiagnostic Systems , Ltd.
Decision Date2016-11-15
Product CodeMRG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set is a medical device manufactured by Immunodiagnostic Systems , Ltd.. It received FDA 510(k) clearance on 2016-11-15 under approval number K161831. 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 IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set?

IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set is a medical device that received FDA 510(k) clearance on 2016-11-15. It is manufactured by Immunodiagnostic Systems , Ltd.. The 510(k) number is K161831.

When was IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set approved by the FDA?

IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set received FDA 510(k) clearance on 2016-11-15, under approval number K161831.

What company makes IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set?

IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set is manufactured by Immunodiagnostic Systems , Ltd..

What is the FDA product code for IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set?

The FDA product code for IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set is MRG.

Other Devices by Immunodiagnostic Systems , Ltd.

K161082IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers K161158IDS-iSYS Intact PTHN K190121IDS SHBG K200475IDS-iSYS Ostase BAP K202136IDS Cortisol

Related Devices (Code: MRG)

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. 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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