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510(k) K161831

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

K161831 is an FDA 510(k) premarket notification submitted by Immunodiagnostic Systems , Ltd. for the device "IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set". The FDA issued a decision of Substantially Equivalent on November 15, 2016. The device falls under product code MRG (System, Test, Vitamin D), a Class II device regulated under 21 CFR 862.1825. Immunodiagnostic Systems , Ltd. has at least 10 other 510(k) clearances on record.

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

Other clearances by Immunodiagnostic Systems , Ltd.

  • K202136 — IDS Cortisol (April 13, 2021)
  • K200475 — IDS-iSYS Ostase BAP (September 30, 2020)
  • K190121 — IDS SHBG (June 17, 2019)
  • K161158 — IDS-iSYS Intact PTHN (January 31, 2017)
  • K161082 — IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration (May 17, 2016)
  • K142351 — 25-Hydroxy Vitamin Ds EIA (August 25, 2015)
  • K142994 — IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone (April 21, 2015)
  • K143324 — IDS-iSYS CTX-I Calibration Verifiers (March 30, 2015)
  • K140554 — IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SET (December 19, 2014)
  • K123763 — IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIR (December 24, 2013)

Other clearances for product code MRG

  • K232587 — MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay ana (April 12, 2024)
  • K221817 — ALFIS Vitamin D, ALFIS-3 Analyzer (September 22, 2023)
  • K223503 — Access 25(OH) Vitamin D Total (January 19, 2023)
  • K210901 — Elecsys Vitamin D total III (September 1, 2021)
  • K200509 — ADVIA Centaur Vitamin D Total (VitD) (May 29, 2020)
  • K191499 — MAGLUMI 2000 25-OH Vitamin D (August 1, 2019)
  • K180577 — BioPlex 2200 25-OH Vitamin D Kit (June 22, 2018)
  • K172992 — Diazyme EZ Vitamin D Assay (January 11, 2018)
  • K162298 — LOCI Total Vitamin D Total Assay, LOCI VITD CAL (March 16, 2017)
  • K162840 — Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D to (February 8, 2017)

FDA data resources