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FDA 510(k)

AXIS-SHIELD ACVTIVE-B12

K-Number: K121946 · 2013-03-22

ApplicantAxis-Shield Diagnostics, Ltd.
Decision Date2013-03-22
Product CodeCDD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AXIS-SHIELD ACVTIVE-B12 is the device name listed in this FDA 510(k) record. The listed applicant is Axis-Shield Diagnostics, Ltd.. It received FDA 510(k) clearance on 2013-03-22 under 510(k) number K121946. 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 AXIS-SHIELD ACVTIVE-B12?

AXIS-SHIELD ACVTIVE-B12 is a medical device that received FDA 510(k) clearance on 2013-03-22. The listed applicant is Axis-Shield Diagnostics, Ltd.. The 510(k) number is K121946.

When did AXIS-SHIELD ACVTIVE-B12 receive FDA 510(k) clearance?

AXIS-SHIELD ACVTIVE-B12 received FDA 510(k) clearance on 2013-03-22, under 510(k) number K121946.

Who is the listed applicant for AXIS-SHIELD ACVTIVE-B12?

The FDA 510(k) record lists Axis-Shield Diagnostics, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AXIS-SHIELD ACVTIVE-B12?

The FDA product code for AXIS-SHIELD ACVTIVE-B12 is CDD.

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Other records listing Axis-Shield Diagnostics, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253539Alere NT-proBNP for Alinity iK241176Alere NT-proBNP for Alinity i Reagent KitK233541ARCHITECT Active-B12 (Holotranscobalamin)K172133ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) AssayK121842ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1CK112790AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON

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Related Devices (Code: CDD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233541ARCHITECT Active-B12 (Holotranscobalamin)Axis-Shield Diagnostics, Ltd.K223289Access Vitamin B12Beckman Coulter, Inc.K190298DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12Beckman Coulter Biomedical GmbHK192064LIAISON Vitamin B12DiaSorin, Inc.K172133ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) AssayAxis-Shield Diagnostics, Ltd.K161721Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls SetDiazyme Laboratories

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.

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