Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ARCHITECT Active-B12 (Holotranscobalamin)

K-Number: K233541 · 2024-07-31

ApplicantAxis-Shield Diagnostics, Ltd.
Decision Date2024-07-31
Product CodeCDD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ARCHITECT Active-B12 (Holotranscobalamin) is a medical device manufactured by Axis-Shield Diagnostics, Ltd.. It received FDA 510(k) clearance on 2024-07-31 under approval number K233541. The device is classified under product code CDD. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARCHITECT Active-B12 (Holotranscobalamin)?

ARCHITECT Active-B12 (Holotranscobalamin) is a medical device that received FDA 510(k) clearance on 2024-07-31. It is manufactured by Axis-Shield Diagnostics, Ltd.. The 510(k) number is K233541.

When was ARCHITECT Active-B12 (Holotranscobalamin) approved by the FDA?

ARCHITECT Active-B12 (Holotranscobalamin) received FDA 510(k) clearance on 2024-07-31, under approval number K233541.

What company makes ARCHITECT Active-B12 (Holotranscobalamin)?

ARCHITECT Active-B12 (Holotranscobalamin) is manufactured by Axis-Shield Diagnostics, Ltd..

What is the FDA product code for ARCHITECT Active-B12 (Holotranscobalamin)?

The FDA product code for ARCHITECT Active-B12 (Holotranscobalamin) is CDD.

Other Devices by Axis-Shield Diagnostics, Ltd.

K172133ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay K241176Alere NT-proBNP for Alinity i Reagent Kit K253539Alere NT-proBNP for Alinity i

Related Devices (Code: CDD)

K161721Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls SetDiazyme Laboratories K160757ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)Axis-Shield Diagnostics Limited K172133ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) AssayAxis-Shield Diagnostics, Ltd. K190298DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12Beckman Coulter Biomedical GmbH K192064LIAISON Vitamin B12DiaSorin, Inc. K223289Access Vitamin B12Beckman Coulter, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑