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510(k) K233541

ARCHITECT Active-B12 (Holotranscobalamin) by Axis-Shield Diagnostics, Ltd. — Product Code CDD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2024
Date Received
November 3, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioassay, Vitamin B12
Device Class
Class II
Regulation Number
862.1810
Review Panel
CH
Submission Type

Other clearances by Axis-Shield Diagnostics, Ltd.

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  • K172133 — ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay (October 27, 2017)
  • K121946 — AXIS-SHIELD ACVTIVE-B12 (March 22, 2013)
  • K121842 — ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C (December 12, 2012)
  • K112790 — AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON (May 7, 2012)
  • K112443 — ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN) (December 19, 2011)
  • K110296 — AXIS-SHIELD ANTI-CCP (August 18, 2011)
  • K083868 — ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P (September 25, 2009)
  • K083222 — AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100 (July 31, 2009)

Other clearances for product code CDD

  • K223289 — Access Vitamin B12 (December 23, 2022)
  • K190298 — DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Acc (October 4, 2019)
  • K192064 — LIAISON Vitamin B12 (October 2, 2019)
  • K172133 — ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay (October 27, 2017)
  • K161721 — Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin (September 20, 2016)
  • K160757 — ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active- (July 26, 2016)
  • K151786 — Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet (September 24, 2015)
  • K140496 — Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYP (September 16, 2014)
  • K133512 — LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL (January 2, 2014)
  • K121946 — AXIS-SHIELD ACVTIVE-B12 (March 22, 2013)