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FDA 510(k)

Access Vitamin B12

K-Number: K223289 · 2022-12-23

ApplicantBeckman Coulter, Inc.
Decision Date2022-12-23
Product CodeCDD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Access Vitamin B12 is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2022-12-23 under approval number K223289. 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 Access Vitamin B12?

Access Vitamin B12 is a medical device that received FDA 510(k) clearance on 2022-12-23. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K223289.

When was Access Vitamin B12 approved by the FDA?

Access Vitamin B12 received FDA 510(k) clearance on 2022-12-23, under approval number K223289.

What company makes Access Vitamin B12?

Access Vitamin B12 is manufactured by Beckman Coulter, Inc..

What is the FDA product code for Access Vitamin B12?

The FDA product code for Access Vitamin B12 is CDD.

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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. K233541ARCHITECT Active-B12 (Holotranscobalamin)Axis-Shield Diagnostics, Ltd.

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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