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510(k) K150270

ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AIA-PACK 25-OH Vitamin D Pretreatment Set by Tosoh Bioscience, Inc. — Product Code MRG

K150270 is an FDA 510(k) premarket notification submitted by Tosoh Bioscience, Inc. for the device "ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AIA-PACK 25-OH Vitamin D Pretreatment Set". The FDA issued a decision of Substantially Equivalent on October 26, 2015. The device falls under product code MRG (System, Test, Vitamin D), a Class II device regulated under 21 CFR 862.1825. Tosoh Bioscience, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2015
Date Received
February 4, 2015
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 Tosoh Bioscience, Inc.

  • K250073 — Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 (October 3, 2025)
  • K211199 — ST AIA-PACK BNP Assay (November 8, 2021)
  • K200904 — Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 (August 5, 2021)
  • K160113 — ST AIA-PACK hsE2 Calibrator Set (February 17, 2016)
  • K153417 — ST AIA-PACK PROG III Calibrator Set (December 18, 2015)
  • K143075 — ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set (July 2, 2015)
  • K143296 — AIA-PACK C-Peptide Control Set (December 16, 2014)
  • K143144 — ST AIA-PACK PROG II Calibrator Set (December 3, 2014)
  • K140648 — ST AIA-PACK C-PEPTIDE II CALIBRATOR SET (April 10, 2014)
  • K131580 — AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-723G8 (January 23, 2014)

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