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510(k) K232587

MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer by Shenzhen New Industries Biomedical Engineering Co., Ltd. — Product Code MRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2024
Date Received
August 25, 2023
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 Shenzhen New Industries Biomedical Engineering Co., Ltd.

  • K192547 — MAGLUMI 2000 HCG/ß-HCG (January 17, 2020)
  • K191499 — MAGLUMI 2000 25-OH Vitamin D (August 1, 2019)
  • K182423 — MAGLUMI 2000 FT4 (October 4, 2018)
  • K162698 — MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer (July 14, 2017)

Other clearances for product code MRG

  • 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)
  • K162754 — FREND Vitamin D Test System (January 12, 2017)