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510(k) K180577

BioPlex 2200 25-OH Vitamin D Kit by Bio-Rad Laboratories — Product Code MRG

K180577 is an FDA 510(k) premarket notification submitted by Bio-Rad Laboratories for the device "BioPlex 2200 25-OH Vitamin D Kit". The FDA issued a decision of Substantially Equivalent on June 22, 2018. The device falls under product code MRG (System, Test, Vitamin D), a Class II device regulated under 21 CFR 862.1825. Bio-Rad Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2018
Date Received
March 5, 2018
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 Bio-Rad Laboratories

  • K183446 — BioPlex 2200 Lyme Total (March 12, 2019)
  • K181661 — QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System (February 13, 2019)
  • K171664 — Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview So (September 13, 2017)
  • K170509 — BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC I (May 19, 2017)
  • K170413 — BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator (May 11, 2017)
  • K163015 — Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; (January 10, 2017)
  • K161687 — D-10 Hemoglobin A1c Program (October 14, 2016)
  • K152679 — Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, (May 10, 2016)
  • DEN150058 — Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 (March 28, 2016)
  • K150300 — Liquichek Cardiac Markers Plus Control LT (December 11, 2015)

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)
  • 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)

FDA data resources