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510(k) K161831

IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set by Immunodiagnostic Systems , Ltd. — Product Code MRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2016
Date Received
July 5, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Vitamin D
Device Class
Class II
Regulation Number
862.1825
Review Panel
CH
Submission Type

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  • K123763 — IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIR (December 24, 2013)

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  • K191499 — MAGLUMI 2000 25-OH Vitamin D (August 1, 2019)
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  • K172992 — Diazyme EZ Vitamin D Assay (January 11, 2018)
  • K162298 — LOCI Total Vitamin D Total Assay, LOCI VITD CAL (March 16, 2017)
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