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510(k) K140554

IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SET by Immunodiagnostic Systems , Ltd. — Product Code MRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2014
Date Received
March 4, 2014
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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  • 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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