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510(k) K133512

LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL) by Siemens Healthcare Diagnostics — Product Code CDD

K133512 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics for the device "LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL)". The FDA issued a decision of Substantially Equivalent on January 2, 2014. The device falls under product code CDD (Radioassay, Vitamin B12), a Class II device regulated under 21 CFR 862.1810. Siemens Healthcare Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 2, 2014
Date Received
November 15, 2013
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

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Other clearances for product code CDD

  • K233541 — ARCHITECT Active-B12 (Holotranscobalamin) (July 31, 2024)
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  • 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)
  • K121946 — AXIS-SHIELD ACVTIVE-B12 (March 22, 2013)

FDA data resources